- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01000727
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)
July 12, 2017 updated by: GlaxoSmithKline
A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy.
Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.
Study Type
Interventional
Enrollment (Actual)
13026
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, 1425
- GSK Investigational Site
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Cipolletti, Argentina, R8324CVM
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
- GSK Investigational Site
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Corrientes, Argentina, W3400AMZ
- GSK Investigational Site
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Haedo, Buenos Aires, Argentina, B1706AJU
- GSK Investigational Site
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San Miguel de Tucuman, Argentina, T4000IFL
- GSK Investigational Site
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Santa fe, Argentina, 3000
- GSK Investigational Site
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Sante Fe, Argentina, S3000FSO
- GSK Investigational Site
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Sante Fe, Argentina, S3000GCI
- GSK Investigational Site
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Tucuman, Argentina, T4000ICL
- GSK Investigational Site
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Zárate, Argentina, B2800DGH
- GSK Investigational Site
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1180AAX
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1179AAB
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AST
- GSK Investigational Site
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
- GSK Investigational Site
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Ramos Mejia, Buenos Aires, Argentina, B1704ETD
- GSK Investigational Site
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San Justo, Buenos Aires, Argentina, B1754FPI
- GSK Investigational Site
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San Nicolas, Buenos Aires, Argentina, B2900DMH
- GSK Investigational Site
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Córdova
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Cordoba, Córdova, Argentina, X5000AAW
- GSK Investigational Site
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Cordoba, Córdova, Argentina, X5000EPU
- GSK Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, 2002
- GSK Investigational Site
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Rosario, Santa Fe, Argentina, S2000BIF
- GSK Investigational Site
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Rosario, Santa Fe, Argentina, S2000CVD
- GSK Investigational Site
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Rosario, Santa Fe, Argentina, S2000ODA
- GSK Investigational Site
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Rosario, Santa Fe, Argentina, S2002OUR
- GSK Investigational Site
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Ashford, Australia, 5035
- GSK Investigational Site
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2606
- GSK Investigational Site
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- GSK Investigational Site
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Gosford, New South Wales, Australia, 2250
- GSK Investigational Site
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Queensland
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Auchenflower, Queensland, Australia, 4066
- GSK Investigational Site
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Herston, Queensland, Australia, 4029
- GSK Investigational Site
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Milton, Queensland, Australia, 4064
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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Elizabeth Vale, South Australia, Australia, 5112
- GSK Investigational Site
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Tasmania
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Hobart, Tasmania, Australia, 7000
- GSK Investigational Site
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Victoria
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Box Hill, Victoria, Australia, 3128
- GSK Investigational Site
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Nedlands, Victoria, Australia, 6009
- GSK Investigational Site
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- GSK Investigational Site
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Aalst, Belgium, 9300
- GSK Investigational Site
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Bonheiden, Belgium, 2820
- GSK Investigational Site
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Brussels, Belgium, 1000
- GSK Investigational Site
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Brussels, Belgium, 1090
- GSK Investigational Site
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Bruxelles, Belgium, 1200
- GSK Investigational Site
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Edegem, Belgium, 2650
- GSK Investigational Site
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Genk, Belgium, 3600
- GSK Investigational Site
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La Louvière, Belgium, 7100
- GSK Investigational Site
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Leuven, Belgium, 3000
- GSK Investigational Site
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Liège, Belgium, 4000
- GSK Investigational Site
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Roeselaere, Belgium, 8800
- GSK Investigational Site
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Bahia, Brazil, 40050-410
- GSK Investigational Site
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Brasília, Brazil, 70658-700
- GSK Investigational Site
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Campinas, Brazil, 13060-803
- GSK Investigational Site
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Campo Grande, Brazil, 79080-090
- GSK Investigational Site
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Rio De Janeiro, Brazil, RJ 22240-000
- GSK Investigational Site
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Rio de Janeiro, Brazil, 21041-030
- GSK Investigational Site
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São Paulo, Brazil, 04012-180
- GSK Investigational Site
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São Paulo, Brazil, 05403000
- GSK Investigational Site
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São Paulo, Brazil, 05508-900
- GSK Investigational Site
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São Paulo - SP, Brazil, 01323-900
- GSK Investigational Site
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Uberlandia, Brazil, 38400-902
- GSK Investigational Site
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Bahía
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Salvador, Bahía, Brazil, 41810010
- GSK Investigational Site
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Ceará
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Fortaleza, Ceará, Brazil, 60864-190
- GSK Investigational Site
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Goiás
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Goiânia - GO, Goiás, Brazil, 74605-020
- GSK Investigational Site
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130-110
- GSK Investigational Site
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Belo Horizonte, Minas Gerais, Brazil, 30150-221.
- GSK Investigational Site
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Paraná
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Campina Grande do Sul, Paraná, Brazil, 83430000
- GSK Investigational Site
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Curitiba, Paraná, Brazil, 80730-150
- GSK Investigational Site
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Rio Grande Do Sul
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Pelotas, Rio Grande Do Sul, Brazil, 96015-290
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90620001
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
- GSK Investigational Site
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Rio Grande Du Norte
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Natal, Rio Grande Du Norte, Brazil, 59020-100
- GSK Investigational Site
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São Paulo
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Marília, São Paulo, Brazil, 17515-000
- GSK Investigational Site
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Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
- GSK Investigational Site
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Sao Paulo, São Paulo, Brazil, 04024-900
- GSK Investigational Site
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São José do Rio Preto, São Paulo, Brazil, 15015210
- GSK Investigational Site
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Votuporanga, São Paulo, Brazil, 15500-003
- GSK Investigational Site
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Dimitrovgrad, Bulgaria, 6400
- GSK Investigational Site
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Haskovo, Bulgaria, 6300
- GSK Investigational Site
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Pleven, Bulgaria, 5800
- GSK Investigational Site
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Plovdiv, Bulgaria, 4002
- GSK Investigational Site
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Plovdiv, Bulgaria, 4003
- GSK Investigational Site
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Sofia, Bulgaria, 1606
- GSK Investigational Site
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Sofia, Bulgaria, 1407
- GSK Investigational Site
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Sofia, Bulgaria, 1527
- GSK Investigational Site
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Sofia, Bulgaria, 1000
- GSK Investigational Site
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Sofia, Bulgaria, 1202
- GSK Investigational Site
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Sofia, Bulgaria, 1709
- GSK Investigational Site
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Veliko Tarnovo, Bulgaria, 5000
- GSK Investigational Site
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- GSK Investigational Site
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British Columbia
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Campbell River, British Columbia, Canada, V9W 5Y4
- GSK Investigational Site
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New Westminister, British Columbia, Canada, V3L 3W4
- GSK Investigational Site
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Surrey, British Columbia, Canada, V3V 1N1
- GSK Investigational Site
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Vancouver, British Columbia, Canada, V5Z 1M9
- GSK Investigational Site
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Victoria, British Columbia, Canada, V8R 4R2
- GSK Investigational Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- GSK Investigational Site
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
- GSK Investigational Site
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- GSK Investigational Site
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Brampton, Ontario, Canada, L6Z 4N5
- GSK Investigational Site
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Cambridge, Ontario, Canada, N1R 6V6
- GSK Investigational Site
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Cambridge, Ontario, Canada, N1R 7R1
- GSK Investigational Site
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Hamilton, Ontario, Canada, L8L 2X2
- GSK Investigational Site
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Kelowna, Ontario, Canada, V1Y 1E4
- GSK Investigational Site
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Mississauga, Ontario, Canada, L5B 2P7
- GSK Investigational Site
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Newmarket, Ontario, Canada, L3Y 8C3
- GSK Investigational Site
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Oshawa, Ontario, Canada, L1J 2J9
- GSK Investigational Site
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Oshawa, Ontario, Canada, L1J 2K1
- GSK Investigational Site
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Ottawa, Ontario, Canada, K1Y 4W7
- GSK Investigational Site
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Sarnia, Ontario, Canada, N7T 4X3
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3C 1S8
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3E 3B8
- GSK Investigational Site
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Thunder Bay, Ontario, Canada, P7B 7C7
- GSK Investigational Site
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Toronto, Ontario, Canada, M4C 3E7
- GSK Investigational Site
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Toronto, Ontario, Canada, M5C 2T2
- GSK Investigational Site
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Quebec
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Greenfield Park, Quebec, Canada, JAV 2GB
- GSK Investigational Site
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Longueuil, Quebec, Canada, J4M 2X1
- GSK Investigational Site
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Montreal, Quebec, Canada, H3G 1A4
- GSK Investigational Site
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Montreal, Quebec, Canada, H1T 3Y7
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 5N4
- GSK Investigational Site
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Thetford Mines, Quebec, Canada, G6G 2V4
- GSK Investigational Site
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Santiago, Chile, 8207257
- GSK Investigational Site
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Santiago, Chile, 8900085
- GSK Investigational Site
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Temuco, Chile
- GSK Investigational Site
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Región De La Araucania
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Temuco, Región De La Araucania, Chile
- GSK Investigational Site
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Región Del Biobio
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Concepción, Región Del Biobio, Chile, 56-41
- GSK Investigational Site
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Talcahuano, Región Del Biobio, Chile, 427 0918
- GSK Investigational Site
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Región Metro De Santiago
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Santiago, Región Metro De Santiago, Chile, 750 0922
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7650018
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 8330024
- GSK Investigational Site
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Valparaíso
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Viña del Mar, Valparaíso, Chile
- GSK Investigational Site
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Beijing, China, 100029
- GSK Investigational Site
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Beijing, China, 100050
- GSK Investigational Site
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Beijing, China, 100730
- GSK Investigational Site
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Beijing, China, 100853
- GSK Investigational Site
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Beijing, China, 100020
- GSK Investigational Site
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Beijing, China, 100037
- GSK Investigational Site
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Hangzhou, China, 310016
- GSK Investigational Site
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Jinan, China, 250012
- GSK Investigational Site
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Shanghai, China, 200040
- GSK Investigational Site
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Shanghai, China, 200003
- GSK Investigational Site
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Shanghai, China, 200065
- GSK Investigational Site
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Suzhou, China, 215004
- GSK Investigational Site
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Gansu
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Lanzhou, Gansu, China, 730030
- GSK Investigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510080
- GSK Investigational Site
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Guangzhou, Guangdong, China, 510120
- GSK Investigational Site
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Guangxi
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Nanning, Guangxi, China, 530021
- GSK Investigational Site
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Hainan
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Haikou, Hainan, China, 570102
- GSK Investigational Site
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Hebei
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Shijiazhuang, Hebei, China, 050000
- GSK Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- GSK Investigational Site
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Liaoning
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Dalian, Liaoning, China, 116027
- GSK Investigational Site
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Shenyang, Liaoning, China, 110004
- GSK Investigational Site
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Shenyang, Liaoning, China, 110016
- GSK Investigational Site
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Shaanxi
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Xian, Shaanxi, China, 710061
- GSK Investigational Site
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Shandong
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Jinan, Shandong, China, 250033
- GSK Investigational Site
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Sichuan
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Chengdu, Sichuan, China, 610041
- GSK Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- GSK Investigational Site
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Armenia, Colombia
- GSK Investigational Site
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Barranquilla, Colombia
- GSK Investigational Site
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Bogota, Colombia
- GSK Investigational Site
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Bogota, Colombia, 38007
- GSK Investigational Site
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Bogota, Colombia, 5600520
- GSK Investigational Site
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Bogotá, Colombia
- GSK Investigational Site
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Bucaramanga, Colombia
- GSK Investigational Site
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Cartagena, Colombia
- GSK Investigational Site
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Manizales, Colombia
- GSK Investigational Site
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Medellin, Colombia
- GSK Investigational Site
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Medellín, Colombia
- GSK Investigational Site
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Brno, Czechia, 625 00
- GSK Investigational Site
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Brno, Czechia, 656 91
- GSK Investigational Site
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Caslav, Czechia, 286 01
- GSK Investigational Site
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Jihlava, Czechia, 586 33
- GSK Investigational Site
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Kromeriz, Czechia, 767 55
- GSK Investigational Site
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Milevsko, Czechia, 399 01
- GSK Investigational Site
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Olomouc, Czechia, 775 20
- GSK Investigational Site
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Plzen - Bory, Czechia, 305 99
- GSK Investigational Site
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Praha 10, Czechia, 100 34
- GSK Investigational Site
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Praha 2, Czechia, 128 08
- GSK Investigational Site
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Slany, Czechia
- GSK Investigational Site
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Svitavy, Czechia, 568 25
- GSK Investigational Site
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Usti nad Orlici, Czechia, 562 18
- GSK Investigational Site
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Zlin, Czechia, 762 75
- GSK Investigational Site
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Aalborg, Denmark, DK-9000
- GSK Investigational Site
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Aarhus, Denmark, DK-8000
- GSK Investigational Site
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Esbjerg, Denmark, 6700
- GSK Investigational Site
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Frederikssund, Denmark, DK-3600
- GSK Investigational Site
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Glostrup, Denmark, DK-2600
- GSK Investigational Site
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Hellerup, Denmark, 2900
- GSK Investigational Site
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Herlev, Denmark, DK-2730
- GSK Investigational Site
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Holbæk, Denmark, DK-4300
- GSK Investigational Site
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Hvidovre, Denmark, DK-2650
- GSK Investigational Site
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Koebenhavn N, Denmark, 2100
- GSK Investigational Site
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Kolding, Denmark, DK-6000
- GSK Investigational Site
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København NV, Denmark, DK-2400
- GSK Investigational Site
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København S, Denmark, DK-2300
- GSK Investigational Site
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Køge, Denmark, DK-4600
- GSK Investigational Site
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Næstved, Denmark, 4700
- GSK Investigational Site
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Odense C, Denmark, DK-5000
- GSK Investigational Site
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Roskilde, Denmark, 4000
- GSK Investigational Site
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Silkeborg, Denmark, DK-8600
- GSK Investigational Site
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Svendborg, Denmark, 5700
- GSK Investigational Site
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Avignon, France, 84000
- GSK Investigational Site
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Besançon Cedex, France, 25030
- GSK Investigational Site
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Bron, France, 69677
- GSK Investigational Site
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Créteil, France, 94010
- GSK Investigational Site
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Dijon Cedex, France, 21079
- GSK Investigational Site
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Lagny sur Marne, France, 77405
- GSK Investigational Site
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Le Plessis Robinson, France, 92350
- GSK Investigational Site
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Lille, France, 59000
- GSK Investigational Site
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Marseille Cedex 08, France, 13285
- GSK Investigational Site
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Montfermeil, France, 93370
- GSK Investigational Site
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Paris, France, 75651
- GSK Investigational Site
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Paris Cedex 18, France, 75877
- GSK Investigational Site
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Poitiers, France, 86021
- GSK Investigational Site
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Quincy sous Sénart, France, 91480
- GSK Investigational Site
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Rennes, France, 35033
- GSK Investigational Site
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Strasbourg Cedex, France, 67091
- GSK Investigational Site
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Toulouse, France, 31500
- GSK Investigational Site
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Tourcoing, France, 59200
- GSK Investigational Site
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Valenciennes, France, 59300
- GSK Investigational Site
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Aquitaine
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Pau, Aquitaine, France, 64046
- GSK Investigational Site
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Champagne-Ardenne
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Langres, Champagne-Ardenne, France, 52206
- GSK Investigational Site
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Nord-Pas-de-Calais
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Dunkerque, Nord-Pas-de-Calais, France, 59240
- GSK Investigational Site
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Berlin, Germany, 13353
- GSK Investigational Site
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Berlin, Germany, 12351
- GSK Investigational Site
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Berlin, Germany, 12559
- GSK Investigational Site
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Bremen, Germany, 28277
- GSK Investigational Site
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Halle, Germany, 06120
- GSK Investigational Site
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Hamburg, Germany, 20246
- GSK Investigational Site
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Baden-Wuerttemberg
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Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
- GSK Investigational Site
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Freiburg, Baden-Wuerttemberg, Germany, 79106
- GSK Investigational Site
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Heidelberg, Baden-Wuerttemberg, Germany, 69120
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Germany, 70376
- GSK Investigational Site
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Ulm, Baden-Wuerttemberg, Germany, 89081
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Germany, 80336
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81737
- GSK Investigational Site
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Hessen
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Bad Nauheim, Hessen, Germany, 61231
- GSK Investigational Site
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Darmstadt, Hessen, Germany, 64283
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60590
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 65929
- GSK Investigational Site
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Langen, Hessen, Germany, 63225
- GSK Investigational Site
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Limburg, Hessen, Germany, 65549
- GSK Investigational Site
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Niedersachsen
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Bad Rothenfelde, Niedersachsen, Germany, 49214
- GSK Investigational Site
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Hannover, Niedersachsen, Germany, 30625
- GSK Investigational Site
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Oldenburg, Niedersachsen, Germany, 26133
- GSK Investigational Site
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Nordrhein-Westfalen
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Bielefeld, Nordrhein-Westfalen, Germany, 33604
- GSK Investigational Site
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Eschweiler, Nordrhein-Westfalen, Germany, 52249
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45359
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45122
- GSK Investigational Site
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Neuss, Nordrhein-Westfalen, Germany, 41464
- GSK Investigational Site
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Wuppertal, Nordrhein-Westfalen, Germany, 42117
- GSK Investigational Site
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Rheinland-Pfalz
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Ludwigshafen, Rheinland-Pfalz, Germany, 67063
- GSK Investigational Site
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Saarland
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Homburg, Saarland, Germany, 66421
- GSK Investigational Site
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Germany, 24105
- GSK Investigational Site
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Luebeck, Schleswig-Holstein, Germany, 23538
- GSK Investigational Site
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Thueringen
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Altenburg, Thueringen, Germany, 04600
- GSK Investigational Site
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Budapest, Hungary, 1122
- GSK Investigational Site
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Budapest, Hungary, 1032
- GSK Investigational Site
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Budapest, Hungary, 1096
- GSK Investigational Site
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Budapest, Hungary, 1106
- GSK Investigational Site
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Budapest, Hungary, 1125
- GSK Investigational Site
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Budapest, Hungary, 1134
- GSK Investigational Site
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Budapest, Hungary, 1145
- GSK Investigational Site
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Cegléd, Hungary, 2700
- GSK Investigational Site
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Eger, Hungary, 3300
- GSK Investigational Site
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Gyula, Hungary, 5700
- GSK Investigational Site
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Hodmezovasarhely, Hungary, 6800
- GSK Investigational Site
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Kistarcsa, Hungary, 2143
- GSK Investigational Site
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Miskolc, Hungary, 3526
- GSK Investigational Site
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Szolnok, Hungary, 5004
- GSK Investigational Site
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Szombathely, Hungary, 9700
- GSK Investigational Site
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Székesfehérvár, Hungary, 8000
- GSK Investigational Site
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Zalaegerszeg, Hungary, 8900
- GSK Investigational Site
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Ahmedabad, India, 380052
- GSK Investigational Site
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Ahmedabad, India, 380060
- GSK Investigational Site
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Amritsar, India, 143004
- GSK Investigational Site
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Chennai, India, 600037
- GSK Investigational Site
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Chennai, India, 600081
- GSK Investigational Site
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Faridabad, India, 121001
- GSK Investigational Site
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Gandhinagar, India, 382428
- GSK Investigational Site
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Gurgaon, India, 122001
- GSK Investigational Site
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Hyderabad, India, 500001
- GSK Investigational Site
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Hyderabad, India, 500020
- GSK Investigational Site
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Hyderabad, India, 500033
- GSK Investigational Site
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Hyderabad, India, 500063
- GSK Investigational Site
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Hyderabad, India, 500082
- GSK Investigational Site
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Indore, India, 452018
- GSK Investigational Site
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Jaipur, India, 302017
- GSK Investigational Site
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Lucknow, India, 226014
- GSK Investigational Site
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Mohali, India, 160062
- GSK Investigational Site
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New Delhi, India, 110060
- GSK Investigational Site
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New Delhi, India, 110025
- GSK Investigational Site
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New Delhi, India, 110070
- GSK Investigational Site
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Noida, India, 201301
- GSK Investigational Site
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Patiala, India, 147001
- GSK Investigational Site
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Pune, India, 411004
- GSK Investigational Site
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Pune,, India, 411001
- GSK Investigational Site
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Secunderabad,, India, 500003
- GSK Investigational Site
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Vadodara, India, 390015
- GSK Investigational Site
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Visakhapatnam, India, 530002
- GSK Investigational Site
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Ashkelon, Israel, 78278
- GSK Investigational Site
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Beer Sheva, Israel, 84350
- GSK Investigational Site
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Haddera, Israel, 38100
- GSK Investigational Site
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Haifa, Israel, 31096
- GSK Investigational Site
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Haifa, Israel, 31048
- GSK Investigational Site
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Haifa, Israel, 34362
- GSK Investigational Site
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Holon, Israel, 58100
- GSK Investigational Site
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Jerusalem, Israel, 91031
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Jerusalem, Israel, 91120
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Jerusalem, Israel, 91004
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Jerusalem, Israel, 91240
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Kfar Saba, Israel, 44281
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Nahariya, Israel, 22100
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Poriya, Israel, 15208
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Raanana, Israel, 43000
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Ramat-Gan, Israel, 52621
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Rehovot, Israel, 76100
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Safed, Israel, 13110
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Tel Aviv, Israel, 64239
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Legnano, Italy, 20025
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Sassuolo, Italy, 41049
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Calabria
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Catanzaro, Calabria, Italy, 88100
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Campania
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Napoli, Campania, Italy, 80131
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
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Carpi, Emilia-Romagna, Italy, 41012
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Ferrara, Emilia-Romagna, Italy, 44100
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Parma, Emilia-Romagna, Italy, 43100
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Friuli-Venezia-Giulia
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Palmanova, Friuli-Venezia-Giulia, Italy, 33057
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San Daniele del Friuli, Friuli-Venezia-Giulia, Italy, 33038
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Udine, Friuli-Venezia-Giulia, Italy, 33100
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Lazio
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Roma, Lazio, Italy, 00135
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Roma, Lazio, Italy, 00168
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Roma, Lazio, Italy, 00189
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Lombardia
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Bergamo, Lombardia, Italy, 24128
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Milano, Lombardia, Italy, 20162
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Rozzano (Mi), Lombardia, Italy, 20089
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Marche
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Ascoli Piceno, Marche, Italy, 63100
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Piemonte
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Novara, Piemonte, Italy, 28100
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Sardegna
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Sassari, Sardegna, Italy, 07100
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Toscana
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Pisa, Toscana, Italy, 56126
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Veneto
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Treviso, Veneto, Italy, 31100
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Chiba, Japan, 270-2251
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Fukuoka, Japan, 816-0864
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Fukuoka, Japan, 807-0051
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Fukuoka, Japan, 811-0213
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Hokkaido, Japan, 063-0005
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Hokkaido, Japan, 006-8555
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Hokkaido, Japan, 065-0033
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Hyogo, Japan, 650-0047
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Kanagawa, Japan, 247-8533
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Kanagawa, Japan, 232-0024
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Kanagawa, Japan, 243-8551
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Kyoto, Japan, 606-8507
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Nagasaki, Japan, 856-8562
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Oita, Japan, 870-0263
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Okayama, Japan, 700-8558
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Osaka, Japan, 565-8565
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Osaka, Japan, 574-0074
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Osaka, Japan, 580-0032
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Saga, Japan, 843-0393
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Shizuoka, Japan, 410-2295
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Tokyo, Japan, 160-8582
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Tokyo, Japan, 196-0003
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Tokyo, Japan, 101-8643
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Tokyo, Japan, 113-8431
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Dae-Gu, Korea, Republic of, 700-721
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Daejeon, Korea, Republic of, 301721
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Gangnam-gu, Seoul, Korea, Republic of, 135-710
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Gwangju, Korea, Republic of, 501-757
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Kangwon-do, Korea, Republic of, 220-701
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Pusan, Korea, Republic of, 602-739
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 137-701
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Seoul, Korea, Republic of, 110-744
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's-Hertogenbosch, Netherlands, 5223 GZ
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Amersfoort, Netherlands, 3818 ES
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Amsterdam, Netherlands, 1105 AZ
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Amsterdam, Netherlands, 1091 AC
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Amsterdam, Netherlands, 1061 AE
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Apeldoorn, Netherlands, 7334 DZ
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Blaricum, Netherlands, 1261 AN
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Den Haag, Netherlands, 2597 AX
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Deventer, Netherlands, 7416 SE
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Dirksland, Netherlands, 3247 BW
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Doetinchem, Netherlands, 7009 BL
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Drachten, Netherlands, 9202 NN
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Eindhoven, Netherlands, 5623 EJ
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Gorinchem, Netherlands, 4204 AA
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Gouda, Netherlands, 2803 HH
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Groningen, Netherlands, 9728 NT
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Hardenberg, Netherlands, 7772 SE
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Harderwijk, Netherlands, 3844 DG
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Heerenveen, Netherlands, 8441 PW
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Heerlen, Netherlands, 6419 PC
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Helmond, Netherlands, 5707 HA
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Hilversum, Netherlands, 1213 XZ
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Hoofddorp, Netherlands, 2134 TM
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Hoorn, Netherlands, 1625 HV
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Nijmegen, Netherlands, 6532 SZ
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OSS, Netherlands, 5342 BT
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Roermond, Netherlands, 6043 CV
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Rotterdam, Netherlands, 3083 AN
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Rotterdam, Netherlands, 3045 PM
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Sittard-geleen, Netherlands, 6162 BG
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Sneek, Netherlands, 8601 ZR
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Tiel, Netherlands, 4002 WP
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Tilburg, Netherlands, 5042AD
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Veldhoven, Netherlands, 5504 DB
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Venlo, Netherlands, 5912 BL
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Zoetermeer, Netherlands, 2725 NA
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Auckland, New Zealand, 2025
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Auckland, New Zealand
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Christchurch, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand, 3204
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Lower Hutt, New Zealand, 6007
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New Plymouth, New Zealand, 4310
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Palmerston North, New Zealand
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Takapuna, Auckland, New Zealand, 0622
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Tauranga, New Zealand
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Whangarei, New Zealand
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Callao, Peru, Callao 02
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Lima, Peru, Lima 11
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Lima, Peru, Lima 27
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Lima, Peru, Lima 33
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Lima Cercado, Peru, LIMA 01
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Lima
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Miraflores, Lima, Lima, Peru, Lima 18
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San Martin de Porres, Lima, Peru, Lima 31
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Cebu City, Philippines, 6000
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Davao, Philippines, 8000
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Manila, Philippines, 1000
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Quezon City, Philippines, 1113
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Quezon City, Philippines, 1100
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Quezon City, Philippines, 1109
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Bialystok, Poland, 15-276
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Bydgoszcz, Poland, 85-079
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Bytom, Poland, 41-902
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Chrzanow, Poland, 32-500
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Gdansk, Poland, 80-952
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Gdynia, Poland, 81-423
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Gdynia, Poland, 81-472
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Gdynia, Poland, 81-519
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Inowroclaw, Poland
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Krakow, Poland, 31-121
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Krakow, Poland, 31-202
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Lodz, Poland, 91-347
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Lubin, Poland, 59-300
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Mielec, Poland, 39-300
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Olawa, Poland, 55-200
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Opole, Poland, 45-418
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Radom, Poland, 26-617
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Skierniewice, Poland, 96-100
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Tarnow, Poland, 33-100
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Torun, Poland, 87-100
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Tychy, Poland, 43-100
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Walbrzych, Poland, 58-309
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Warsaw, Poland, 02-507
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Warszawa, Poland, 00-685
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Warszawa, Poland, 02-637
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Warszawa, Poland, 04-073
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Wloclawek, Poland, 87-800
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Wroclaw, Poland, 50-367
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Wroclaw, Poland, 50-349
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Wroclaw, Poland, 51-124
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Zamosc, Poland, 22-400
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Zielona Gora, Poland, 65-046
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Baia Mare, Romania, 430123
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Braila, Romania, 810249
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Brasov, Romania, 500326
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Bucharest, Romania, 022328
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Bucharest, Romania, 050098
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Bucharest, Romania, 011461
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Bucharest, Romania, 011794
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Bucharest, Romania, 014461
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Bucharest, Romania, 041915
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Cluj-Napoca, Romania, 400001
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Constanta, Romania, 900591
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Craiova, Romania, 200642
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Iasi, Romania, 700503
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Targu Mures, Romania, 540136
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Barnaul, Russian Federation, 656024
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Ekaterinburg, Russian Federation, 620039
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Ekaterinburg, Russian Federation, 620109
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Gatchina, Russian Federation, 188300
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Kemerovo, Russian Federation, 650002
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Kemerovo, Russian Federation, 650036
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Krasnoyarsk, Russian Federation, 660097
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Moscow, Russian Federation, 117292
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Moscow, Russian Federation, 119991
- GSK Investigational Site
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Moscow, Russian Federation, 105187
- GSK Investigational Site
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Moscow, Russian Federation, 111020
- GSK Investigational Site
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Moscow, Russian Federation, 111539
- GSK Investigational Site
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Moscow, Russian Federation, 119620
- GSK Investigational Site
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Moscow, Russian Federation, 121 309
- GSK Investigational Site
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Moscow, Russian Federation, 121552
- GSK Investigational Site
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Moscow, Russian Federation, 127018
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Moscow, Russian Federation, 127473
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Nizhniy Novgorod, Russian Federation, 603035
- GSK Investigational Site
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Nizhniy Novgorod, Russian Federation, 603076
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Novosibirsk, Russian Federation, 630008
- GSK Investigational Site
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Novosibirsk, Russian Federation, 630047
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Orenburg, Russian Federation, 460040
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Samara, Russian Federation, 443070
- GSK Investigational Site
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Saratov, Russian Federation, 410028
- GSK Investigational Site
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Saratov, Russian Federation, 410054
- GSK Investigational Site
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St'Petersburg, Russian Federation, 194156
- GSK Investigational Site
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St-Petersburg, Russian Federation, 193312
- GSK Investigational Site
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St-Petersburg, Russian Federation, 195067
- GSK Investigational Site
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St-Petersburg, Russian Federation, 199106
- GSK Investigational Site
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St. Petersburg, Russian Federation, 196247
- GSK Investigational Site
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St. Petersburg, Russian Federation, 190000
- GSK Investigational Site
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St. Petersburg, Russian Federation, 192242
- GSK Investigational Site
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St. Petersburg, Russian Federation, 193079
- GSK Investigational Site
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St. Petersburg, Russian Federation, 196601
- GSK Investigational Site
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St. Petersburg, Russian Federation, 198013
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St. Petersburg, Russian Federation, 198205
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Tomsk, Russian Federation, 643012
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Tyumen, Russian Federation, 625023
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Tyumen, Russian Federation, 625026
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Yaroslavl, Russian Federation, 150003
- GSK Investigational Site
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Bratislava, Slovakia, 826 06
- GSK Investigational Site
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Bratislava, Slovakia, 813 69
- GSK Investigational Site
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Bratislava, Slovakia, 833 05
- GSK Investigational Site
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Bratislava, Slovakia, 833 48
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Kosice, Slovakia, 040 22
- GSK Investigational Site
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Nitra, Slovakia, 949 01
- GSK Investigational Site
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Nitra, Slovakia, 950 01
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Nove Zamky, Slovakia, 940 52
- GSK Investigational Site
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Goodwood, South Africa, 7460
- GSK Investigational Site
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Kempton Park, South Africa, 1619
- GSK Investigational Site
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Paarl, South Africa, 7646
- GSK Investigational Site
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Parktown West, South Africa, 2193
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Parow, South Africa, 7505
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Pretoria, South Africa, 0002
- GSK Investigational Site
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Pretoria, South Africa, 0041
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Somerset West, South Africa, 7130
- GSK Investigational Site
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Worcester, South Africa, 6850
- GSK Investigational Site
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Free State
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Bloemfontein, Free State, South Africa, 9301
- GSK Investigational Site
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Gauteng
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Alberton, Gauteng, South Africa, 1449
- GSK Investigational Site
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Johannesburg, Gauteng, South Africa, 2000
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Pretoria, Gauteng, South Africa, 0001
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Pretoria, Gauteng, South Africa, 0132
- GSK Investigational Site
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KwaZulu- Natal
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Durban, KwaZulu- Natal, South Africa, 4001
- GSK Investigational Site
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Durban, KwaZulu- Natal, South Africa, 4052
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Western Province
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Cape Town, Western Province, South Africa, 7500
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Cape Town, Western Province, South Africa, 7530
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Panorama, Western Province, South Africa, 7500
- GSK Investigational Site
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Alicante, Spain, 03010
- GSK Investigational Site
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Barcelona, Spain, 08035
- GSK Investigational Site
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Lerida, Spain, 25198
- GSK Investigational Site
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León, Spain, 24071
- GSK Investigational Site
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Madrid, Spain, 28006
- GSK Investigational Site
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Madrid, Spain, 28046
- GSK Investigational Site
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Malaga, Spain, 29010
- GSK Investigational Site
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Oviedo, Spain, 33006
- GSK Investigational Site
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San Juan/Alicante, Spain, 03550
- GSK Investigational Site
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San Sebastián, Spain, 20014
- GSK Investigational Site
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San Sebastián de los Reyes/Madrid, Spain
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Sevilla, Spain, 41009
- GSK Investigational Site
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Valencia, Spain, 46014
- GSK Investigational Site
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Vigo/Pontevedra, Spain, 36200
- GSK Investigational Site
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Göteborg, Sweden, SE-413 45
- GSK Investigational Site
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Göteborg, Sweden, SE-41685
- GSK Investigational Site
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Göteborg, Sweden, SE-43180
- GSK Investigational Site
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Hässleholm, Sweden, SE-28125
- GSK Investigational Site
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Jönköping, Sweden, SE-551 85
- GSK Investigational Site
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Stockholm, Sweden, SE-11883
- GSK Investigational Site
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Västerås, Sweden, SE-721 89
- GSK Investigational Site
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Örebro, Sweden, SE-70185
- GSK Investigational Site
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Östersund, Sweden, SE-831 83
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Kaohsiung, Taiwan, 833
- GSK Investigational Site
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Kaohsiung City, Taiwan, 807
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Taipei, Taiwan, 112
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Taipei, Taiwan, 220
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Taipei, Taiwan, 111
- GSK Investigational Site
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Yung Kang City, Taiwan, 71044
- GSK Investigational Site
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Bangkok, Thailand, 10400
- GSK Investigational Site
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Bangkoknoi, Thailand, 10700
- GSK Investigational Site
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Chiangmai, Thailand, 50200
- GSK Investigational Site
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Khon Kaen, Muang, Thailand, 40002
- GSK Investigational Site
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Nakhon Ratchasima, Thailand, 30000
- GSK Investigational Site
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Pathumthani, Thailand, 12120
- GSK Investigational Site
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Ankara, Turkey, 06500
- GSK Investigational Site
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Erzurum, Turkey, 25240
- GSK Investigational Site
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Eskisehir, Turkey, 26480
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Izmir, Turkey, 35100
- GSK Investigational Site
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Izmir, Turkey, 35340
- GSK Investigational Site
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Izmir, Turkey, 35360
- GSK Investigational Site
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Dnipropetrovsk, Ukraine, 49006
- GSK Investigational Site
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Donetsk, Ukraine, 83114
- GSK Investigational Site
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Kharkiv, Ukraine, 61039
- GSK Investigational Site
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Kharkiv, Ukraine, 61002
- GSK Investigational Site
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Kharkiv, Ukraine, 61018
- GSK Investigational Site
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Kharkiv, Ukraine, 61176
- GSK Investigational Site
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Kyiv, Ukraine, 02091
- GSK Investigational Site
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Kyiv, Ukraine, 03680
- GSK Investigational Site
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Kyiv, Ukraine, 01601
- GSK Investigational Site
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Kyiv, Ukraine, 02660
- GSK Investigational Site
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Kyiv, Ukraine, 03049
- GSK Investigational Site
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Kyiv, Ukraine, 3115
- GSK Investigational Site
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Lugansk, Ukraine, 91045
- GSK Investigational Site
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Lutsk, Ukraine, 43024
- GSK Investigational Site
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Mykolaiv, Ukraine, 54033
- GSK Investigational Site
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Odesa, Ukraine, 65014
- GSK Investigational Site
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Simferopol, Ukraine, 95026
- GSK Investigational Site
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Vinnytsia, Ukraine, 21018
- GSK Investigational Site
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Vinnytsia, Ukraine, 21029
- GSK Investigational Site
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Zaporizhzhya, Ukraine, 69000
- GSK Investigational Site
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Antrim, United Kingdom, BT41 2RL
- GSK Investigational Site
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Chichester, United Kingdom, PO19 6SE
- GSK Investigational Site
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East Kilbride, United Kingdom, G75 8RG
- GSK Investigational Site
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Hertfordshire, United Kingdom
- GSK Investigational Site
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Liverpool, United Kingdom, L7 8XP
- GSK Investigational Site
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Paisley, United Kingdom, PA2 9PN
- GSK Investigational Site
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Stirling, United Kingdom, FK8 2AU
- GSK Investigational Site
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Devon
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Exeter, Devon, United Kingdom, EX2 5DW
- GSK Investigational Site
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Torquay, Devon, United Kingdom, TQ2 7AA
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Lanarkshire
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Airdrie, Lanarkshire, United Kingdom, ML6 0JS
- GSK Investigational Site
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Middlesex
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Harrow, Middlesex, United Kingdom, HA1 3UJ
- GSK Investigational Site
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Northamptonshire
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Northampton, Northamptonshire, United Kingdom, NN1 5BD
- GSK Investigational Site
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Nottinghamshire
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Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
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Surrey
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Chertsey, Surrey, United Kingdom, KT16 0PZ
- GSK Investigational Site
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West Midlands
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Coventry, West Midlands, United Kingdom, CV2 2DX
- GSK Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35294
- GSK Investigational Site
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Birmingham, Alabama, United States, 35243
- GSK Investigational Site
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Huntsville, Alabama, United States, 35801
- GSK Investigational Site
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Mobile, Alabama, United States, 36608
- GSK Investigational Site
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Mobile, Alabama, United States, 36604
- GSK Investigational Site
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Alaska
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Anchorage, Alaska, United States, 99508
- GSK Investigational Site
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Arizona
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Cottonwood, Arizona, United States, 86326
- GSK Investigational Site
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Glendale, Arizona, United States, 85306
- GSK Investigational Site
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Tucson, Arizona, United States, 85710
- GSK Investigational Site
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Tucson, Arizona, United States, 85723
- GSK Investigational Site
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Tucson, Arizona, United States, 85724
- GSK Investigational Site
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Arkansas
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Fort Smith, Arkansas, United States, 72903
- GSK Investigational Site
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Jonesboro, Arkansas, United States, 72401
- GSK Investigational Site
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Little Rock, Arkansas, United States, 72205
- GSK Investigational Site
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California
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Bakersfield, California, United States, 93308
- GSK Investigational Site
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Bakersfield, California, United States, 93309
- GSK Investigational Site
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Beverly Hills, California, United States, 90211
- GSK Investigational Site
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Fresno, California, United States, 93721
- GSK Investigational Site
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Glendale, California, United States, 91204
- GSK Investigational Site
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La Mesa, California, United States, 91942
- GSK Investigational Site
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Lomita, California, United States, 90717
- GSK Investigational Site
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Los Alamitos, California, United States, 90720
- GSK Investigational Site
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Los Angeles, California, United States, 90073
- GSK Investigational Site
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Los Angeles, California, United States, 90015
- GSK Investigational Site
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Mission Hills, California, United States, 91345
- GSK Investigational Site
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Roseville, California, United States, 95661
- GSK Investigational Site
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Sacramento, California, United States, 95819
- GSK Investigational Site
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San Diego, California, United States, 92161
- GSK Investigational Site
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Santa Ana, California, United States, 92704
- GSK Investigational Site
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Santa Ana, California, United States, 92705
- GSK Investigational Site
-
Stockton, California, United States, 95204
- GSK Investigational Site
-
Thousand Oaks, California, United States, 91360
- GSK Investigational Site
-
Torrance, California, United States, 90509
- GSK Investigational Site
-
Ventura, California, United States, 93003
- GSK Investigational Site
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80920
- GSK Investigational Site
-
Golden, Colorado, United States, 80401
- GSK Investigational Site
-
Greeley, Colorado, United States, 80631
- GSK Investigational Site
-
Littleton, Colorado, United States, 80120
- GSK Investigational Site
-
Wheat Ridge, Colorado, United States, 80033
- GSK Investigational Site
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06606
- GSK Investigational Site
-
Bridgeport, Connecticut, United States, 06610
- GSK Investigational Site
-
Guilford, Connecticut, United States, 06437
- GSK Investigational Site
-
Hartford, Connecticut, United States, 06067
- GSK Investigational Site
-
-
Florida
-
Atlantis, Florida, United States, 33462
- GSK Investigational Site
-
Aventura, Florida, United States, 33180
- GSK Investigational Site
-
Brandon, Florida, United States, 33511
- GSK Investigational Site
-
Clearwater, Florida, United States, 33756
- GSK Investigational Site
-
Daytona Beach, Florida, United States, 32114
- GSK Investigational Site
-
Daytona Beach, Florida, United States, 32117
- GSK Investigational Site
-
Fleming Island, Florida, United States, 32003
- GSK Investigational Site
-
Fort Lauderdale, Florida, United States, 33316
- GSK Investigational Site
-
Gainesville, Florida, United States, 32610
- GSK Investigational Site
-
Gulf Breeze, Florida, United States, 32561
- GSK Investigational Site
-
Hollywood, Florida, United States, 33021
- GSK Investigational Site
-
Inverness, Florida, United States, 34452
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32216
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32209
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32207
- GSK Investigational Site
-
Jacksonville Beach, Florida, United States, 32250
- GSK Investigational Site
-
Jupiter, Florida, United States, 33458
- GSK Investigational Site
-
Kissimmee, Florida, United States, 34741
- GSK Investigational Site
-
Miramar, Florida, United States, 33025
- GSK Investigational Site
-
Ocala, Florida, United States, 34471
- GSK Investigational Site
-
Palm Beach Gardens, Florida, United States, 33410
- GSK Investigational Site
-
Pensacola, Florida, United States, 32501
- GSK Investigational Site
-
Plantation, Florida, United States, 33317
- GSK Investigational Site
-
Port Charlotte, Florida, United States, 33952
- GSK Investigational Site
-
Safety Harbor, Florida, United States, 34695
- GSK Investigational Site
-
Saint Petersburg, Florida, United States, 33713
- GSK Investigational Site
-
Sarasota, Florida, United States, 34232
- GSK Investigational Site
-
Tallahassee, Florida, United States, 32308
- GSK Investigational Site
-
Trinity, Florida, United States, 34655
- GSK Investigational Site
-
Vero Beach, Florida, United States, 32960
- GSK Investigational Site
-
Wellington, Florida, United States, 33449
- GSK Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- GSK Investigational Site
-
Augusta, Georgia, United States, 30901
- GSK Investigational Site
-
Cumming, Georgia, United States, 30041
- GSK Investigational Site
-
-
Idaho
-
Boise, Idaho, United States, 83712
- GSK Investigational Site
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- GSK Investigational Site
-
Bannockburn, Illinois, United States, 60015
- GSK Investigational Site
-
Chicago, Illinois, United States, 60612
- GSK Investigational Site
-
Melrose Park, Illinois, United States, 60160
- GSK Investigational Site
-
Mokena, Illinois, United States, 60448
- GSK Investigational Site
-
North Chicago, Illinois, United States, 60064
- GSK Investigational Site
-
Oakbrook Terrace, Illinois, United States, 60181
- GSK Investigational Site
-
Park Ridge, Illinois, United States, 60068
- GSK Investigational Site
-
Peoria, Illinois, United States, 61614
- GSK Investigational Site
-
Rock Island, Illinois, United States, 61201
- GSK Investigational Site
-
-
Indiana
-
Avon, Indiana, United States, 46123
- GSK Investigational Site
-
Fort Wayne, Indiana, United States, 46804
- GSK Investigational Site
-
Hammond, Indiana, United States, 46320
- GSK Investigational Site
-
Indianapolis, Indiana, United States, 46237
- GSK Investigational Site
-
Indianapolis, Indiana, United States, 46290
- GSK Investigational Site
-
Muncie, Indiana, United States, 47303
- GSK Investigational Site
-
Munster, Indiana, United States, 46321
- GSK Investigational Site
-
South Bend, Indiana, United States, 46601-1066
- GSK Investigational Site
-
Valparaiso, Indiana, United States, 46383
- GSK Investigational Site
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- GSK Investigational Site
-
West Des Moines, Iowa, United States, 50266
- GSK Investigational Site
-
-
Kentucky
-
Crestview Hills, Kentucky, United States, 41017
- GSK Investigational Site
-
Lexington, Kentucky, United States, 40536-0294
- GSK Investigational Site
-
Louisville, Kentucky, United States, 40207
- GSK Investigational Site
-
Louisville, Kentucky, United States, 40205
- GSK Investigational Site
-
-
Louisiana
-
Alexandria, Louisiana, United States, 71301
- GSK Investigational Site
-
Lafayette, Louisiana, United States, 70506
- GSK Investigational Site
-
Lake Charles, Louisiana, United States, 70601
- GSK Investigational Site
-
Shreveport, Louisiana, United States, 71105
- GSK Investigational Site
-
-
Maine
-
Bangor, Maine, United States, 04401
- GSK Investigational Site
-
Lewiston, Maine, United States, 04240
- GSK Investigational Site
-
Scarborough, Maine, United States, 04074
- GSK Investigational Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- GSK Investigational Site
-
Baltimore, Maryland, United States, 21236
- GSK Investigational Site
-
Baltimore, Maryland, United States, 21208
- GSK Investigational Site
-
Baltimore, Maryland, United States, 21218
- GSK Investigational Site
-
Baltimore, Maryland, United States, 21229
- GSK Investigational Site
-
Bel Air, Maryland, United States, 21014
- GSK Investigational Site
-
Columbia, Maryland, United States, 21044
- GSK Investigational Site
-
Salisbury, Maryland, United States, 21801
- GSK Investigational Site
-
Towson, Maryland, United States, 21204
- GSK Investigational Site
-
-
Massachusetts
-
Ayer, Massachusetts, United States, 01432
- GSK Investigational Site
-
Boston, Massachusetts, United States, 02111
- GSK Investigational Site
-
Boston, Massachusetts, United States, 02115
- GSK Investigational Site
-
Fall River, Massachusetts, United States, 02720
- GSK Investigational Site
-
Springfield, Massachusetts, United States, 01199
- GSK Investigational Site
-
Worcester, Massachusetts, United States, 01655
- GSK Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- GSK Investigational Site
-
Dearborn, Michigan, United States, 48124
- GSK Investigational Site
-
Detroit, Michigan, United States, 48201
- GSK Investigational Site
-
Flint, Michigan, United States, 48532
- GSK Investigational Site
-
Kalamazoo, Michigan, United States, 49048
- GSK Investigational Site
-
Marquette, Michigan, United States, 49855
- GSK Investigational Site
-
Pontiac, Michigan, United States, 48341-2985
- GSK Investigational Site
-
Troy, Michigan, United States, 48085
- GSK Investigational Site
-
Ypsilanti, Michigan, United States, 48197
- GSK Investigational Site
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- GSK Investigational Site
-
Minneapolis, Minnesota, United States, 55426
- GSK Investigational Site
-
Robbinsdale, Minnesota, United States, 55422
- GSK Investigational Site
-
Saint Cloud, Minnesota, United States, 56303
- GSK Investigational Site
-
Saint Paul, Minnesota, United States, 55101
- GSK Investigational Site
-
-
Mississippi
-
Tupelo, Mississippi, United States, 38801
- GSK Investigational Site
-
-
Missouri
-
Columbia, Missouri, United States, 65212
- GSK Investigational Site
-
Joplin, Missouri, United States, 64804
- GSK Investigational Site
-
Kansas City, Missouri, United States, 64114
- GSK Investigational Site
-
Saint Louis, Missouri, United States, 63110
- GSK Investigational Site
-
Saint Louis, Missouri, United States, 63128
- GSK Investigational Site
-
Springfield, Missouri, United States, 65804
- GSK Investigational Site
-
-
Montana
-
Columbia Falls, Montana, United States, 65201
- GSK Investigational Site
-
Great Falls, Montana, United States, 59405
- GSK Investigational Site
-
Kalispell, Montana, United States, 59901
- GSK Investigational Site
-
-
Nebraska
-
Grand Island, Nebraska, United States, 68803
- GSK Investigational Site
-
Lincoln, Nebraska, United States, 68526
- GSK Investigational Site
-
Omaha, Nebraska, United States, 68131
- GSK Investigational Site
-
Papillion, Nebraska, United States, 68046
- GSK Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, United States, 89103
- GSK Investigational Site
-
-
New Jersey
-
Browns Mills, New Jersey, United States, 08015
- GSK Investigational Site
-
Elizabeth, New Jersey, United States, 07202
- GSK Investigational Site
-
Elmer, New Jersey, United States, 8318
- GSK Investigational Site
-
Haddon Heights, New Jersey, United States, 08035
- GSK Investigational Site
-
Linden, New Jersey, United States, 07036
- GSK Investigational Site
-
Paterson, New Jersey, United States, 07503
- GSK Investigational Site
-
Pomona, New Jersey, United States, 8240
- GSK Investigational Site
-
Sewell, New Jersey, United States, 08080
- GSK Investigational Site
-
Somerset, New Jersey, United States, 08873
- GSK Investigational Site
-
Summit, New Jersey, United States, 07902
- GSK Investigational Site
-
Voorhees, New Jersey, United States, 08043
- GSK Investigational Site
-
West Orange, New Jersey, United States, 07052
- GSK Investigational Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131-0001
- GSK Investigational Site
-
-
New York
-
Albany, New York, United States, 12211
- GSK Investigational Site
-
Brooklyn, New York, United States, 11219
- GSK Investigational Site
-
Buffalo, New York, United States, 14215
- GSK Investigational Site
-
New York, New York, United States, 10021
- GSK Investigational Site
-
New York, New York, United States, 10016
- GSK Investigational Site
-
New York, New York, United States, 10001
- GSK Investigational Site
-
Peekskill, New York, United States, 10567
- GSK Investigational Site
-
Roslyn, New York, United States, 11576
- GSK Investigational Site
-
Stony Brook, New York, United States, 11794
- GSK Investigational Site
-
Syracuse, New York, United States, 13202
- GSK Investigational Site
-
The Bronx, New York, United States, 10467
- GSK Investigational Site
-
Troy, New York, United States, 12180
- GSK Investigational Site
-
Williamsville, New York, United States, 14221
- GSK Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, United States, 28803
- GSK Investigational Site
-
Burlington, North Carolina, United States, 27215
- GSK Investigational Site
-
Charlotte, North Carolina, United States, 28204
- GSK Investigational Site
-
Concord, North Carolina, United States, 28025
- GSK Investigational Site
-
Gastonia, North Carolina, United States, 28054
- GSK Investigational Site
-
Greensboro, North Carolina, United States, 27401
- GSK Investigational Site
-
Huntersville, North Carolina, United States, 28078
- GSK Investigational Site
-
Matthews, North Carolina, United States, 28105
- GSK Investigational Site
-
Monroe, North Carolina, United States, 28112
- GSK Investigational Site
-
Pinehurst, North Carolina, United States, 28374
- GSK Investigational Site
-
Raleigh, North Carolina, United States, 27610
- GSK Investigational Site
-
Rocky Mount, North Carolina, United States, 27804
- GSK Investigational Site
-
Salisbury, North Carolina, United States, 28144
- GSK Investigational Site
-
Sanford, North Carolina, United States, 27330
- GSK Investigational Site
-
Winston-Salem, North Carolina, United States, 27157
- GSK Investigational Site
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58201
- GSK Investigational Site
-
-
Ohio
-
Canton, Ohio, United States, 44718
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45219
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45267
- GSK Investigational Site
-
Cleveland, Ohio, United States, 44106
- GSK Investigational Site
-
Dayton, Ohio, United States, 45414
- GSK Investigational Site
-
Elyria, Ohio, United States, 44035
- GSK Investigational Site
-
Fairfield, Ohio, United States, 45014
- GSK Investigational Site
-
Fairview Park, Ohio, United States, 44126
- GSK Investigational Site
-
Lorain, Ohio, United States, 44053
- GSK Investigational Site
-
Mansfield, Ohio, United States, 44906
- GSK Investigational Site
-
Middleburg Heights, Ohio, United States, 44130
- GSK Investigational Site
-
Oakbrook Terrace, Ohio, United States, 60181
- GSK Investigational Site
-
Sandusky, Ohio, United States, 44870
- GSK Investigational Site
-
Toledo, Ohio, United States, 43614
- GSK Investigational Site
-
Toledo, Ohio, United States, 43606
- GSK Investigational Site
-
Youngstown, Ohio, United States, 44501-1790
- GSK Investigational Site
-
Zanesville, Ohio, United States, 43701
- GSK Investigational Site
-
-
Oklahoma
-
Midwest City, Oklahoma, United States, 73110
- GSK Investigational Site
-
Oklahoma City, Oklahoma, United States, 73104
- GSK Investigational Site
-
Oklahoma City, Oklahoma, United States, 73112
- GSK Investigational Site
-
-
Oregon
-
Portland, Oregon, United States, 97239
- GSK Investigational Site
-
Portland, Oregon, United States, 97220
- GSK Investigational Site
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- GSK Investigational Site
-
Beaver, Pennsylvania, United States, 15009
- GSK Investigational Site
-
Bethlehem, Pennsylvania, United States, 18015
- GSK Investigational Site
-
Camp Hill, Pennsylvania, United States, 17011
- GSK Investigational Site
-
Chambersburg, Pennsylvania, United States, 17201
- GSK Investigational Site
-
Doylestown, Pennsylvania, United States, 18901
- GSK Investigational Site
-
Erie, Pennsylvania, United States, 16502
- GSK Investigational Site
-
Hershey, Pennsylvania, United States, 17033
- GSK Investigational Site
-
Jenkintown, Pennsylvania, United States, 19046
- GSK Investigational Site
-
Jersey Shore, Pennsylvania, United States, 17740
- GSK Investigational Site
-
Lancaster, Pennsylvania, United States, 17604
- GSK Investigational Site
-
Lansdale, Pennsylvania, United States, 19446
- GSK Investigational Site
-
Leetsdale, Pennsylvania, United States, 15056
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19141
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15212
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15240
- GSK Investigational Site
-
Sayre, Pennsylvania, United States, 18840
- GSK Investigational Site
-
Scranton, Pennsylvania, United States, 18501
- GSK Investigational Site
-
Sellersville, Pennsylvania, United States, 18960
- GSK Investigational Site
-
West Chester, Pennsylvania, United States, 19380
- GSK Investigational Site
-
York, Pennsylvania, United States, 17405
- GSK Investigational Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- GSK Investigational Site
-
Charleston, South Carolina, United States, 29401
- GSK Investigational Site
-
Columbia, South Carolina, United States, 29204
- GSK Investigational Site
-
Greenville, South Carolina, United States, 29607
- GSK Investigational Site
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- GSK Investigational Site
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37404
- GSK Investigational Site
-
Columbia, Tennessee, United States, 38401
- GSK Investigational Site
-
Jackson, Tennessee, United States, 38085
- GSK Investigational Site
-
Jackson, Tennessee, United States, 38301
- GSK Investigational Site
-
Johnson City, Tennessee, United States, 37604
- GSK Investigational Site
-
Nashville, Tennessee, United States, 37205
- GSK Investigational Site
-
Oak Ridge, Tennessee, United States, 37830
- GSK Investigational Site
-
-
Texas
-
Amarillo, Texas, United States, 79106
- GSK Investigational Site
-
Austin, Texas, United States, 78705
- GSK Investigational Site
-
Corpus Christi, Texas, United States, 78404
- GSK Investigational Site
-
Dallas, Texas, United States, 75226
- GSK Investigational Site
-
Dallas, Texas, United States, 75390-8887
- GSK Investigational Site
-
Fort Worth, Texas, United States, 76104
- GSK Investigational Site
-
Galveston, Texas, United States, 77555-0553
- GSK Investigational Site
-
Harker Heights, Texas, United States, 76548
- GSK Investigational Site
-
Houston, Texas, United States, 77030
- GSK Investigational Site
-
Houston, Texas, United States, 77090
- GSK Investigational Site
-
Houston, Texas, United States, 77002
- GSK Investigational Site
-
Houston, Texas, United States, 77124
- GSK Investigational Site
-
Katy, Texas, United States, 77493
- GSK Investigational Site
-
Kingwood, Texas, United States, 77339
- GSK Investigational Site
-
Round Rock, Texas, United States, 78681
- GSK Investigational Site
-
San Antonio, Texas, United States, 78229
- GSK Investigational Site
-
San Marcos, Texas, United States, 78666
- GSK Investigational Site
-
Sugar Land, Texas, United States, 77479
- GSK Investigational Site
-
Tyler, Texas, United States, 75708
- GSK Investigational Site
-
Victoria, Texas, United States, 77901
- GSK Investigational Site
-
-
Virginia
-
Lynchburg, Virginia, United States, 24501
- GSK Investigational Site
-
Midlothian, Virginia, United States, 23114
- GSK Investigational Site
-
Richmond, Virginia, United States, 23249
- GSK Investigational Site
-
Richmond, Virginia, United States, 23298
- GSK Investigational Site
-
Richmond, Virginia, United States, 23294
- GSK Investigational Site
-
Winchester, Virginia, United States, 22601
- GSK Investigational Site
-
-
Washington
-
Bellevue, Washington, United States, 98004
- GSK Investigational Site
-
Bellingham, Washington, United States, 98225
- GSK Investigational Site
-
Burien, Washington, United States, 98166
- GSK Investigational Site
-
Everett, Washington, United States, 98201
- GSK Investigational Site
-
Kirkland, Washington, United States, 98034
- GSK Investigational Site
-
Spokane, Washington, United States, 99204
- GSK Investigational Site
-
Spokane, Washington, United States, 99204-2334
- GSK Investigational Site
-
Tacoma, Washington, United States, 98405
- GSK Investigational Site
-
Walla Walla, Washington, United States, 99362
- GSK Investigational Site
-
-
Wisconsin
-
Beloit, Wisconsin, United States, 53511
- GSK Investigational Site
-
Green Bay, Wisconsin, United States, 54301
- GSK Investigational Site
-
Madison, Wisconsin, United States, 53713
- GSK Investigational Site
-
Wausau, Wisconsin, United States, 54401
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent.
- Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
- Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.
- Clinically stable for 24 hours prior to study entry.
- A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.
- At least one of the following:
- At least 60 years old.
- Myocardial infarction prior to the qualifying ACS event.
- Diabetes mellitus requiring treatment with medication.
- Diagnosed mild or moderate reduction in kidney function.
- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.
Exclusion Criteria:
- ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.
- No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).
- Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.
- Certain types of liver disease.
- Severe reduction in kidney function OR removal of a kidney OR kidney transplant.
- Severe heart failure.
- Blood pressure higher than normal despite lifestyle changes and treatment with medications.
- Any life-threatening disease with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.
- Severe asthma that is poorly controlled with medication.
- Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).
- Previous severe allergic reaction to food, medications, drink, insect stings, etc.
- Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.
- Certain medications that may interfere with the study medication (these will be identified by the study doctor).
- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.
- Previously took darapladib (SB-480848).
- Participation in a study of an investigational medication within the past 30 days.
- Current participation in a study of an investigational device.
- Any other reason the investigator deems the subject should not participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Darapladib 160 mg
Single daily oral tablet
|
Lp-PLA2 inhibitor
Other Names:
Guideline mandated therapy for individual's condition
|
|
Placebo Comparator: Placebo
Single daily oral tablet
|
Guideline mandated therapy for individual's condition
Placebo administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.
Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.
|
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure.
Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
|
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
|
Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure.
Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
|
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
|
Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
|
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
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Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
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Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization.
PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
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Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
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CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events).
Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission.
NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia.
Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
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Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included.
Examples include coronary artery bypass graft, balloon angioplasty and stenting.
The number of participants, with first occurrence of any coronary revascularization procedures, were reported.
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
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Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
|
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
|
Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.
|
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
|
Number of Participants With All-cause Mortality During the Time Period for Vital Status
Time Frame: From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
|
Number of participants who died, during the vital status time-period were reported.
The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.
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From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.
- Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10):e006959. doi: 10.1161/JAHA.117.006959.
- Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1):e004332. doi: 10.1161/JAHA.116.004332.
- O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators, Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061. Erratum In: JAMA. 2014 Oct 8;312(14):1473. Dylan P. Steen[corrected to Dylan L. Steen].
- O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 24, 2014
Study Registration Dates
First Submitted
October 22, 2009
First Submitted That Met QC Criteria
October 22, 2009
First Posted (Estimate)
October 23, 2009
Study Record Updates
Last Update Posted (Actual)
August 10, 2017
Last Update Submitted That Met QC Criteria
July 12, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 480848/033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
-
Clinical Study Report
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Study Protocol
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Dataset Specification
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Individual Participant Data Set
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Informed Consent Form
Information identifier: 480848/033Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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