The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial (STABILITY)

July 12, 2017 updated by: GlaxoSmithKline

LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease 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 stroke) in people with coronary heart disease.

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, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.

Study Type

Interventional

Enrollment (Actual)

15828

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

      • Buenos Aires, Argentina, 1425
        • GSK Investigational Site
      • Corrientes, Argentina, W3400AMZ
        • GSK Investigational Site
      • Corrientes, Argentina, W3400CLH
        • GSK Investigational Site
      • Mendoza, Argentina, M5500CCG
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
      • Tucuman, Argentina, T4000ICL
        • GSK Investigational Site
    • Buenos Aires
      • Adrogue, Buenos Aires, Argentina, B1846DSK
        • GSK Investigational Site
      • Bahia Blanca, Buenos Aires, Argentina, B8000FTD
        • GSK Investigational Site
      • Caba, Buenos Aires, Argentina, C1124AAJ
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1125ABD
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1437JCP
        • GSK Investigational Site
      • Junin, Buenos Aires, Argentina
        • GSK Investigational Site
      • La Plata, Buenos Aires, Argentina, B1900AXI
        • GSK Investigational Site
      • Mar del Plata, Buenos Aires, Argentina, B7600FZN
        • GSK Investigational Site
      • Ramos Mejia, Buenos Aires, Argentina, B1704ETD
        • GSK Investigational Site
    • Córdova
      • Cordoba, Córdova, Argentina, X5000EPU
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CVD
        • GSK Investigational Site
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • GSK Investigational Site
      • Concord, New South Wales, Australia, 2139
        • GSK Investigational Site
      • Gosford, New South Wales, Australia, 2250
        • GSK Investigational Site
      • Liverpool, New South Wales, Australia, 2170
        • GSK Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Sherwood, Queensland, Australia, 4075
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
    • Victoria
      • Ballarat, Victoria, Australia
        • GSK Investigational Site
      • Caulfield South, Victoria, Australia, 3162
        • GSK Investigational Site
      • Frankston, Victoria, Australia, 3199
        • GSK Investigational Site
      • Malvern, Victoria, Australia, 3144
        • GSK Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • GSK Investigational Site
      • Joondalup, Western Australia, Australia, 6027
        • GSK Investigational Site
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
      • Aalst, Belgium, 9300
        • GSK Investigational Site
      • Antwerpen, Belgium, 2020
        • GSK Investigational Site
      • Bonheiden, Belgium, 2820
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Genk, Belgium, 3600
        • GSK Investigational Site
      • Hasselt, Belgium, 3500
        • GSK Investigational Site
      • La Louvière, Belgium, 7100
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Roeselaere, Belgium, 8800
        • GSK Investigational Site
      • Yvoir, Belgium, 5530
        • GSK Investigational Site
      • Rio de Janeiro, Brazil, 20551-030
        • GSK Investigational Site
      • São Paulo, Brazil, 05403000
        • GSK Investigational Site
      • São Paulo, Brazil, 05403-000
        • GSK Investigational Site
      • São Paulo, Brazil, 04012-909
        • GSK Investigational Site
      • São Paulo, Brazil, 04012180
        • GSK Investigational Site
    • Bahía
      • Salvador, Bahía, Brazil, 41810010
        • GSK Investigational Site
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-050
        • GSK Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221.
        • GSK Investigational Site
      • Belo Horizonte, Minas Gerais, Brazil, 30380090
        • GSK Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80730150
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015-290
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90880-480
        • GSK Investigational Site
    • Rio Grande Du Norte
      • Natal, Rio Grande Du Norte, Brazil, 59020-100
        • GSK Investigational Site
    • São Paulo
      • Campinas, São Paulo, Brazil, 13059740
        • GSK Investigational Site
      • São José do Rio Preto, São Paulo, Brazil, 15015210
        • GSK Investigational Site
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • GSK Investigational Site
      • Dimitrovgrad, Bulgaria, 6400
        • GSK Investigational Site
      • Pleven, Bulgaria, 5800
        • GSK Investigational Site
      • Plovdiv, Bulgaria, 4003
        • GSK Investigational Site
      • Ruse, Bulgaria, 7002
        • GSK Investigational Site
      • Sofia, Bulgaria, 1431
        • GSK Investigational Site
      • Sofia, Bulgaria, 1606
        • GSK Investigational Site
      • Sofia, Bulgaria, 1527
        • GSK Investigational Site
      • Sofia, Bulgaria, 1233
        • GSK Investigational Site
      • Sofia, Bulgaria, 1000
        • GSK Investigational Site
      • Veliko Tarnovo, Bulgaria, 5000
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • GSK Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1E4
        • GSK Investigational Site
      • New Westminister, British Columbia, Canada, V3L 3W4
        • GSK Investigational Site
      • New Westminster, British Columbia, Canada, V3L 3W4
        • GSK Investigational Site
      • Surrey, British Columbia, Canada, V3V 1N1
        • GSK Investigational Site
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8R 4R2
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
        • GSK Investigational Site
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 7K8
        • GSK Investigational Site
      • Brampton, Ontario, Canada, L6Z 4N5
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2M 5N6
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5B 2P7
        • GSK Investigational Site
      • Oshawa, Ontario, Canada, L1J 2J9
        • GSK Investigational Site
      • Ottawa, Ontario, Canada, K1Y 4W7
        • GSK Investigational Site
      • Scarborough, Ontario, Canada, M1E 5E9
        • GSK Investigational Site
      • Thornhill, Ontario, Canada, L4J 8L7
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3H 5S4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5C 2T2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4G 3E8
        • GSK Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S8
        • GSK Investigational Site
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Levis, Quebec, Canada, G6V 4Z5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1T 3Y7
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1T 1C8
        • GSK Investigational Site
      • Quebec City, Quebec, Canada, G1J 1Z6
        • GSK Investigational Site
      • Quebec City, Quebec, Canada, G1L 3L5
        • GSK Investigational Site
      • Saint Charles-Borromee, Quebec, Canada, J6E 6J2
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1J 2E3
        • GSK Investigational Site
      • Trois Rivières, Quebec, Canada, G8T 7A1
        • GSK Investigational Site
    • Región Del Biobio
      • Talcahuano, Región Del Biobio, Chile, 427 0918
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 8380456
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 750 0922
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7571831
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 8360160
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 7500503
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile, 833 0074
        • GSK Investigational Site
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
        • GSK Investigational Site
      • Beijing, China, 100044
        • GSK Investigational Site
      • Beijing, China, 100034
        • GSK Investigational Site
      • Beijing, China, 100730
        • GSK Investigational Site
      • Beijing, China, 100853
        • GSK Investigational Site
      • Guangzhou, China, 510100
        • GSK Investigational Site
      • Haerbin, China, 150001
        • GSK Investigational Site
      • Shanghai, China, 200040
        • GSK Investigational Site
      • Shanghai, China, 200127
        • GSK Investigational Site
      • Shanghai, China, 200032
        • GSK Investigational Site
      • Shanghai, China, 200233
        • GSK Investigational Site
      • Wuhan, China, 430022
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • GSK Investigational Site
    • Shaanxi
      • Xian, Shaanxi, China, 710061
        • GSK Investigational Site
    • Shandong
      • Jinan, Shandong, China, 250012
        • GSK Investigational Site
    • Zhejiang
      • Hang Zhou, Zhejiang, China, 310003
        • GSK Investigational Site
      • Caslav, Czechia, 286 01
        • GSK Investigational Site
      • Chomutov, Czechia, 430 02
        • GSK Investigational Site
      • Chrudim, Czechia, 537 27
        • GSK Investigational Site
      • Jihlava, Czechia, 586 33
        • GSK Investigational Site
      • Kladno, Czechia, 272 80
        • GSK Investigational Site
      • Kolin, Czechia, 280 00
        • GSK Investigational Site
      • Kromeriz, Czechia, 767 55
        • GSK Investigational Site
      • Milevsko, Czechia, 399 01
        • GSK Investigational Site
      • Pisek, Czechia, 397 01
        • GSK Investigational Site
      • Praha 2, Czechia, 128 08
        • GSK Investigational Site
      • Pribram, Czechia, 261 26
        • GSK Investigational Site
      • Slany, Czechia
        • GSK Investigational Site
      • Svitavy, Czechia, 568 25
        • GSK Investigational Site
      • Tabor, Czechia, 390 03
        • GSK Investigational Site
      • Usti nad Orlici, Czechia, 562 18
        • GSK Investigational Site
      • Aarhus, Denmark, DK-8000
        • GSK Investigational Site
      • Esbjerg, Denmark, 6700
        • GSK Investigational Site
      • Koebenhavn OE, Denmark, 2100
        • GSK Investigational Site
      • Silkeborg, Denmark, 8600
        • GSK Investigational Site
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tallinn, Estonia, 1162
        • GSK Investigational Site
      • Tartu, Estonia, 51014
        • GSK Investigational Site
      • Aix en Provence cedex 1, France, 13616
        • GSK Investigational Site
      • Avignon, France, 84082
        • GSK Investigational Site
      • Besançon Cedex, France, 25030
        • GSK Investigational Site
      • Bron Cedex, France, 69677
        • GSK Investigational Site
      • Créteil, France, 94010
        • GSK Investigational Site
      • Dijon, France, 21079
        • GSK Investigational Site
      • Lille Cedex, France, 59037
        • GSK Investigational Site
      • Marseille cedex 5, France, 13385
        • GSK Investigational Site
      • Metz Cedex 03, France, 57085
        • GSK Investigational Site
      • Nantes Cedex 1, France, 44093
        • GSK Investigational Site
      • Narbonne Cedex, France, 11108
        • GSK Investigational Site
      • Nimes, France, 30000
        • GSK Investigational Site
      • Paris, France, 75015
        • GSK Investigational Site
      • Paris, France, 75010
        • GSK Investigational Site
      • Paris Cedex 13, France, 75651
        • GSK Investigational Site
      • Paris Cedex 18, France, 75877
        • GSK Investigational Site
      • Pessac cedex, France, 33604
        • GSK Investigational Site
      • Roubaix, France, 59056
        • GSK Investigational Site
      • Strasbourg cedex, France, 67091
        • GSK Investigational Site
      • Toulouse Cedex 09, France, 31059
        • GSK Investigational Site
      • Tourcoing, France, 59208
        • GSK Investigational Site
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 13347
        • GSK Investigational Site
      • Berlin, Germany, 10559
        • GSK Investigational Site
      • Berlin, Germany, 12157
        • GSK Investigational Site
      • Berlin, Germany, 13405
        • GSK Investigational Site
      • Hamburg, Germany, 22041
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Deggingen, Baden-Wuerttemberg, Germany, 73326
        • GSK Investigational Site
      • Gueglingen, Baden-Wuerttemberg, Germany, 74363
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
      • Ulm, Baden-Wuerttemberg, Germany, 89081
        • GSK Investigational Site
    • Bayern
      • Aschaffenburg, Bayern, Germany, 63739
        • GSK Investigational Site
      • Haag, Bayern, Germany, 83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
        • GSK Investigational Site
      • Kuenzing, Bayern, Germany, 94550
        • GSK Investigational Site
      • Muehldorf, Bayern, Germany, 84453
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80336
        • GSK Investigational Site
      • Sulzbach-Rosenberg, Bayern, Germany, 92237
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
    • Brandenburg
      • Bernau, Brandenburg, Germany, 16321
        • GSK Investigational Site
    • Hessen
      • Frankfurt/M., Hessen, Germany, 60594
        • GSK Investigational Site
      • Kelkheim, Hessen, Germany, 65779
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
      • Weyhe-Leeste, Niedersachsen, Germany, 28844
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
        • GSK Investigational Site
      • Dorsten, Nordrhein-Westfalen, Germany, 46282
        • GSK Investigational Site
      • Eschweiler, Nordrhein-Westfalen, Germany, 52249
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Herford, Nordrhein-Westfalen, Germany, 32049
        • GSK Investigational Site
      • Lienen-Kattenvenne, Nordrhein-Westfalen, Germany, 49536
        • GSK Investigational Site
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
    • Sachsen
      • Delitzsch, Sachsen, Germany, 04509
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzg, Sachsen, Germany, 04109
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04315
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04329
        • GSK Investigational Site
      • Schmiedeberg, Sachsen, Germany, 01762
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • GSK Investigational Site
      • Agia Varvara, Athens, Greece, 123 51
        • GSK Investigational Site
      • Alexandroupolis, Greece, 68100
        • GSK Investigational Site
      • Athens, Greece, 11527
        • GSK Investigational Site
      • Athens, Greece, 124 62
        • GSK Investigational Site
      • Athens, Greece, 176 74
        • GSK Investigational Site
      • Chalkida, Greece, 341 00
        • GSK Investigational Site
      • Ioannina, Greece, 45500
        • GSK Investigational Site
      • Magoula, Elefsina, Greece, 192 00
        • GSK Investigational Site
      • Patras, Greece, 26 500
        • GSK Investigational Site
      • Thessaloniki, Greece, 546 42
        • GSK Investigational Site
      • Voula / Athens, Greece, 166 73
        • GSK Investigational Site
      • Hong Kong, Hong Kong
        • GSK Investigational Site
      • Shatin, New Territories, Hong Kong
        • GSK Investigational Site
      • Berettyóújfalu, Hungary
        • GSK Investigational Site
      • Budapest, Hungary, 1032
        • GSK Investigational Site
      • Budapest, Hungary, 1096
        • GSK Investigational Site
      • Budapest, Hungary, 1033
        • GSK Investigational Site
      • Esztergom, Hungary
        • GSK Investigational Site
      • Gyula, Hungary, 5700
        • GSK Investigational Site
      • Komárom, Hungary, 2921
        • GSK Investigational Site
      • Mosonmagyaróvár, Hungary, 9200
        • GSK Investigational Site
      • Szikszó, Hungary
        • GSK Investigational Site
      • Szolnok, Hungary, 5004
        • GSK Investigational Site
      • Székesfehérvár, Hungary, 8000
        • GSK Investigational Site
      • Sátoraljaújhely, Hungary, 3980
        • GSK Investigational Site
      • Ahmedabad, India, 380060
        • GSK Investigational Site
      • Bangalore, India, 560034
        • GSK Investigational Site
      • Bangalore, India, 560 099
        • GSK Investigational Site
      • Cochin, India, 683572
        • GSK Investigational Site
      • Jaipur, India, 302017
        • GSK Investigational Site
      • Jaipur, India, 302001
        • GSK Investigational Site
      • Mysore, India, 570020
        • GSK Investigational Site
      • New Delhi, India, 110060
        • GSK Investigational Site
      • Patiala, India, 147001
        • GSK Investigational Site
      • Pune, India, 411004
        • GSK Investigational Site
      • Pune, India, 411030
        • GSK Investigational Site
      • Saket,Delhi, India, 110017
        • GSK Investigational Site
      • Vadodara, India, 390015
        • GSK Investigational Site
      • Vijayawada, India, 520008
        • GSK Investigational Site
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66013
        • GSK Investigational Site
    • Campania
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Carpi, Emilia-Romagna, Italy, 41012
        • GSK Investigational Site
      • Cona (Ferrara), Emilia-Romagna, Italy, 44124
        • GSK Investigational Site
      • Parma, Emilia-Romagna, Italy, 43100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00135
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20162
        • GSK Investigational Site
    • Marche
      • Ascoli Piceno, Marche, Italy, 63100
        • GSK Investigational Site
    • Piemonte
      • Cuneo, Piemonte, Italy, 12100
        • GSK Investigational Site
      • Novara, Piemonte, Italy, 28100
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • GSK Investigational Site
    • Veneto
      • Treviso, Veneto, Italy, 31100
        • GSK Investigational Site
      • Aichi, Japan, 487-0013
        • GSK Investigational Site
      • Chiba, Japan, 270-2251
        • GSK Investigational Site
      • Fukuoka, Japan, 802-8555
        • GSK Investigational Site
      • Fukuoka, Japan, 811-3195
        • GSK Investigational Site
      • Fukuoka, Japan, 819-1104
        • GSK Investigational Site
      • Hokkaido, Japan, 063-0005
        • GSK Investigational Site
      • Hokkaido, Japan, 065-0033
        • GSK Investigational Site
      • Kagoshima, Japan, 892-0853
        • GSK Investigational Site
      • Kanagawa, Japan, 247-8533
        • GSK Investigational Site
      • Kanagawa, Japan, 240-0116
        • GSK Investigational Site
      • Kyoto, Japan, 611-0042
        • GSK Investigational Site
      • Nagano, Japan, 386-8610
        • GSK Investigational Site
      • Nagasaki, Japan, 856-8562
        • GSK Investigational Site
      • Nagasaki, Japan, 859-3615
        • GSK Investigational Site
      • Oita, Japan, 870-1133
        • GSK Investigational Site
      • Osaka, Japan, 574-0074
        • GSK Investigational Site
      • Shiga, Japan, 520-2192
        • GSK Investigational Site
      • Shizuoka, Japan, 411-8611
        • GSK Investigational Site
      • Tokyo, Japan, 141-0001
        • GSK Investigational Site
      • Cheongju, Korea, Republic of, 361-711
        • GSK Investigational Site
      • Dae-Gu, Korea, Republic of, 700-721
        • GSK Investigational Site
      • Gangnam-gu, Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
      • Gwangju, Korea, Republic of, 501-757
        • GSK Investigational Site
      • Seo-gu Busan, Korea, Republic of, 602-739
        • GSK Investigational Site
      • Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 143-729
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 130-702
        • GSK Investigational Site
      • Uijeongbu-si Kyonggi-do, Korea, Republic of, 480-717
        • GSK Investigational Site
      • jeonju-si, Jeollabuk-Do, Korea, Republic of, 561-712
        • GSK Investigational Site
      • Durango, Mexico, 34080
        • GSK Investigational Site
      • Mexico, Mexico, 10700
        • GSK Investigational Site
      • México D.F,, Mexico, 07760
        • GSK Investigational Site
    • Nuevo León
      • Monterrey NL, Nuevo León, Mexico, 64718
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Beverwijk, Netherlands, 1942 LE
        • GSK Investigational Site
      • Den Haag, Netherlands, 2597 AX
        • GSK Investigational Site
      • Doetinchem, Netherlands, 7009 BL
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • GSK Investigational Site
      • Enschede, Netherlands, 7513 ER
        • GSK Investigational Site
      • Goes, Netherlands, 4462 RA
        • GSK Investigational Site
      • Harderwijk, Netherlands, 3844 DG
        • GSK Investigational Site
      • Hoofddorp, Netherlands, 2134 TM
        • GSK Investigational Site
      • Leeuwarden, Netherlands, 8934 AD
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3079 DZ
        • GSK Investigational Site
      • Sittard-geleen, Netherlands, 6162 BG
        • GSK Investigational Site
      • Sneek, Netherlands, 8601 ZK
        • GSK Investigational Site
      • Tiel, Netherlands, 4002 WP
        • GSK Investigational Site
      • Christchurch, New Zealand
        • GSK Investigational Site
      • Dunedin, New Zealand
        • GSK Investigational Site
      • Grafton, Auckland, New Zealand, 1030
        • GSK Investigational Site
      • Hamilton, New Zealand, 3204
        • GSK Investigational Site
      • Lower Hutt, New Zealand
        • GSK Investigational Site
      • Nelson, New Zealand
        • GSK Investigational Site
      • Otahuhu, Auckland, New Zealand, 1640
        • GSK Investigational Site
      • Palmerston North, New Zealand, 4410
        • GSK Investigational Site
      • Takapuna, Auckland, New Zealand, 0622
        • GSK Investigational Site
      • Tauranga, New Zealand, 3112
        • GSK Investigational Site
      • Timaru, New Zealand, 7910
        • GSK Investigational Site
      • Whangarei, New Zealand
        • GSK Investigational Site
      • Bergen, Norway, 5021
        • GSK Investigational Site
      • Moss, Norway, 1501
        • GSK Investigational Site
      • Oslo, Norway, 0407
        • GSK Investigational Site
      • Oslo, Norway, 0160
        • GSK Investigational Site
      • Karachi, Pakistan, 75510
        • GSK Investigational Site
      • Karachi, Pakistan, 75950
        • GSK Investigational Site
      • Korangi / Karachi, Pakistan
        • GSK Investigational Site
      • Lahore, Pakistan, 54000
        • GSK Investigational Site
      • Lahore, Pakistan
        • GSK Investigational Site
      • Multan, Pakistan, 60000
        • GSK Investigational Site
      • Rawalpindi Cantt, Pakistan, 46000
        • GSK Investigational Site
      • Callao, Peru, Callao 2
        • GSK Investigational Site
      • Lima, Peru, Lima 11
        • GSK Investigational Site
    • Lima
      • Jesus Maria, Lima, Peru, Lima 11
        • GSK Investigational Site
      • Ermita, Manila, Philippines, 1000
        • GSK Investigational Site
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Manila, Philippines, 1100
        • GSK Investigational Site
      • Quezon City, Philippines, 1113
        • GSK Investigational Site
      • Quezon City, Philippines
        • GSK Investigational Site
      • Quezon City, Philippines, 1109
        • GSK Investigational Site
      • San Juan, Philippines, 1502
        • GSK Investigational Site
      • Bydgoszcz, Poland, 85-079
        • GSK Investigational Site
      • Bydgoszcz, Poland, 85-435
        • GSK Investigational Site
      • Gdynia, Poland, 81-423
        • GSK Investigational Site
      • Kowanowko, Poland
        • GSK Investigational Site
      • Krakow, Poland, 31-202
        • GSK Investigational Site
      • Mielec, Poland, 39-300
        • GSK Investigational Site
      • Ostrow Wielkopolski, Poland, 63-400
        • GSK Investigational Site
      • Plonsk, Poland, 09 - 100
        • GSK Investigational Site
      • Radom, Poland, 26-617
        • GSK Investigational Site
      • Ruda Slaska, Poland, 41-706
        • GSK Investigational Site
      • Siemianowice Slaskie, Poland, 41-100
        • GSK Investigational Site
      • Skierniewice, Poland
        • GSK Investigational Site
      • Torun, Poland, 87-100
        • GSK Investigational Site
      • Tychy, Poland, 43-100
        • GSK Investigational Site
      • Warszawa, Poland, 04-073
        • GSK Investigational Site
      • Warszawa, Poland, 03-285
        • GSK Investigational Site
      • Wloclawek, Poland, 87-800
        • GSK Investigational Site
      • Wroclaw, Poland, 50-349
        • GSK Investigational Site
      • Bucharest, Romania, 022328
        • GSK Investigational Site
      • Bucharest, Romania, 050098
        • GSK Investigational Site
      • Bucharest, Romania, 011461
        • GSK Investigational Site
      • Bucharest, Romania, 011794
        • GSK Investigational Site
      • Bucharest, Romania, 041915
        • GSK Investigational Site
      • Bucharest, Romania, 042122
        • GSK Investigational Site
      • Bucharest, Romania, 011601
        • GSK Investigational Site
      • Deva, Romania, 330084
        • GSK Investigational Site
      • Galati, Romania, 800087
        • GSK Investigational Site
      • Targu Mures, Romania, 540136
        • GSK Investigational Site
      • Ekaterinburg, Russian Federation, 620109
        • GSK Investigational Site
      • Ekaterinburg, Russian Federation, 620144
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650002
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650055
        • GSK Investigational Site
      • Moscow, Russian Federation, 117292
        • GSK Investigational Site
      • Moscow, Russian Federation, 111020
        • GSK Investigational Site
      • Moscow, Russian Federation, 111539
        • GSK Investigational Site
      • Moscow, Russian Federation, 119620
        • GSK Investigational Site
      • Moscow, Russian Federation, 121552
        • GSK Investigational Site
      • Moscow, Russian Federation, 121 552
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630008
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630003
        • GSK Investigational Site
      • Ryazan, Russian Federation, 390026
        • GSK Investigational Site
      • S.-Petresburg, Russian Federation, 195067
        • GSK Investigational Site
      • St Pertersburg, Russian Federation, 196247
        • GSK Investigational Site
      • St'Petersburg, Russian Federation, 194156
        • GSK Investigational Site
      • St-Petersburg, Russian Federation, 193312
        • GSK Investigational Site
      • St-Petersburg, Russian Federation, 195067
        • GSK Investigational Site
      • St-Petersburg, Russian Federation, 199106
        • GSK Investigational Site
      • Yekaterinburg, Russian Federation
        • GSK Investigational Site
      • Bratislava, Slovakia, 813 69
        • GSK Investigational Site
      • Bratislava, Slovakia, 833 05
        • GSK Investigational Site
      • Kosice, Slovakia, 040 22
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
      • Bellville, South Africa, 7531
        • GSK Investigational Site
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Kempton Park, South Africa, 1619
        • GSK Investigational Site
      • Kuils River, South Africa, 7580
        • GSK Investigational Site
      • Moreletapark, South Africa, 0181
        • GSK Investigational Site
      • Olivedale, South Africa, 2188
        • GSK Investigational Site
      • Paarl, South Africa, 7646
        • GSK Investigational Site
      • Parktown West, South Africa, 2193
        • GSK Investigational Site
      • Parow, South Africa, 7505
        • GSK Investigational Site
      • Pinelands, South Africa, 7405
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
      • Soweto, South Africa, 2013
        • GSK Investigational Site
      • Umhlanga, South Africa, 4319
        • GSK Investigational Site
    • Gauteng
      • Parktown, Gauteng, South Africa, 2193
        • GSK Investigational Site
      • Alicante, Spain, 03114
        • GSK Investigational Site
      • Granada, Spain, 18012
        • GSK Investigational Site
      • Jerez de la Frontera, Spain, 11407
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28031
        • GSK Investigational Site
      • Madrid, Spain
        • GSK Investigational Site
      • Madrid, Spain, 28029
        • GSK Investigational Site
      • Malaga, Spain, 29010
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Oviedo, Spain, 33006
        • GSK Investigational Site
      • Pozuelo de Alarcón/Madrid, Spain, 28223
        • GSK Investigational Site
      • San Juan (Alicante), Spain, 03550
        • GSK Investigational Site
      • San Sebastián, Spain, 20014
        • GSK Investigational Site
      • San Sebastián de los Reyes/Madrid, Spain
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
      • Sevilla, Spain, 41071
        • GSK Investigational Site
      • Sta Coloma de Gramanet (Barcelona), Spain, 08923
        • GSK Investigational Site
      • Valdemoro/Madrid, Spain, 28340
        • GSK Investigational Site
      • Eksjö, Sweden, SE-575 36
        • GSK Investigational Site
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Göteborg, Sweden, SE-416 85
        • GSK Investigational Site
      • Linköping, Sweden, SE-581 85
        • GSK Investigational Site
      • Lund, Sweden, SE-222 21
        • GSK Investigational Site
      • Malmö, Sweden, SE-205 02
        • GSK Investigational Site
      • Stockholm, Sweden, SE-182 88
        • GSK Investigational Site
      • Stockholm, Sweden, SE-111 57
        • GSK Investigational Site
      • Stockholm, Sweden, SE-111 35
        • GSK Investigational Site
      • Umeå, Sweden, SE-901 85
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
      • Västervik, Sweden, SE-593 81
        • GSK Investigational Site
      • Västerås, Sweden, SE-721 89
        • GSK Investigational Site
      • Östersund, Sweden, SE-831 83
        • GSK Investigational Site
      • Changhua, Taiwan, 500
        • GSK Investigational Site
      • Taichung, Taiwan, 407
        • GSK Investigational Site
      • Tainan, Taiwan, 704
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taipei City, Taiwan, 104
        • GSK Investigational Site
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • Bangkok, Thailand, 10700
        • GSK Investigational Site
      • Chiangmai, Thailand, 50200
        • GSK Investigational Site
      • Donetsk, Ukraine, 83045
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61037
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61002
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61018
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61176
        • GSK Investigational Site
      • Kyiv, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 02660
        • GSK Investigational Site
      • Kyiv, Ukraine, 04114
        • GSK Investigational Site
      • Lviv, Ukraine, 79044
        • GSK Investigational Site
      • Odesa, Ukraine, 65025
        • GSK Investigational Site
      • Odesa, Ukraine, 65114
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21029
        • GSK Investigational Site
      • Zaporizhzhia, Ukraine, 69118
        • GSK Investigational Site
      • Barnet, United Kingdom, EN5 3DJ
        • GSK Investigational Site
      • Coatbridge, United Kingdom, ML5 3AP
        • GSK Investigational Site
      • Cottingham, United Kingdom, HU16 5JQ
        • GSK Investigational Site
      • Cumbernauld, United Kingdom, G67 1BJ
        • GSK Investigational Site
      • Hamilton, United Kingdom, ML3 8AA
        • GSK Investigational Site
      • Hertfordshire, United Kingdom
        • GSK Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • GSK Investigational Site
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • GSK Investigational Site
      • Paisley, United Kingdom, PA2 9PN
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G11 6NT
        • GSK Investigational Site
      • Motherwell, Lanarkshire, United Kingdom, ML1 3JX
        • GSK Investigational Site
    • London
      • Chelsea, London, United Kingdom, SW3 6NP
        • GSK Investigational Site
    • Merseyside
      • Liverpool, Merseyside, United Kingdom
        • GSK Investigational Site
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • GSK Investigational Site
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
        • GSK Investigational Site
    • Sussex West
      • Chichester, Sussex West, United Kingdom, PO19 4SE
        • GSK Investigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35294-0007
        • GSK Investigational Site
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • GSK Investigational Site
    • California
      • Concord, California, United States, 94520
        • GSK Investigational Site
      • Lomita, California, United States, 90717
        • GSK Investigational Site
      • Los Angeles, California, United States, 90024
        • GSK Investigational Site
      • Los Angeles, California, United States, 90036
        • GSK Investigational Site
      • Madera, California, United States, 93637
        • GSK Investigational Site
      • Oakland, California, United States, 94612
        • GSK Investigational Site
      • Oakland, California, United States, 94611
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
      • Sacramento, California, United States, 95819
        • GSK Investigational Site
      • San Diego, California, United States, 92161
        • GSK Investigational Site
      • San Ramon, California, United States, 94582
        • GSK Investigational Site
      • Santa Ana, California, United States, 92705
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Thousand Oaks, California, United States, 91360
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
        • GSK Investigational Site
      • Denver, Colorado, United States, 80218
        • GSK Investigational Site
      • Golden, Colorado, United States, 80401
        • GSK Investigational Site
      • Thornton, Colorado, United States, 80229
        • GSK Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • GSK Investigational Site
      • Bridgeport, Connecticut, United States, 06610
        • GSK Investigational Site
      • Hartford, Connecticut, United States, 06067
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • GSK Investigational Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32610
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33023
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32216
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32207
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32258
        • GSK Investigational Site
      • Jacksonville Beach, Florida, United States, 32250
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • GSK Investigational Site
      • Miami, Florida, United States, 33183
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • GSK Investigational Site
      • Ponte Vedra Beach, Florida, United States, 32081
        • GSK Investigational Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • GSK Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60654
        • GSK Investigational Site
      • Melrose Park, Illinois, United States, 60160
        • GSK Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • GSK Investigational Site
      • Franklin, Indiana, United States, 46131
        • GSK Investigational Site
      • Greenfield, Indiana, United States, 46140
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46256
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • 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
      • Louisville, Kentucky, United States, 40213
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40206
        • GSK Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
      • New Iberia, Louisiana, United States, 70563
        • GSK Investigational Site
      • Slidell, Louisiana, United States, 70458
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
      • Bangor, Maine, United States, 04401
        • GSK Investigational Site
      • Scarborough, Maine, United States, 04074
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • GSK Investigational Site
      • Oxon Hill, Maryland, United States, 20745
        • GSK Investigational Site
      • Prince Frederick, Maryland, United States, 20678
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • GSK Investigational Site
      • Natick, Massachusetts, United States, 01760
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01103
        • GSK Investigational Site
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • GSK Investigational Site
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Petoskey, Michigan, United States, 49770
        • GSK Investigational Site
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • GSK Investigational Site
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89130
        • GSK Investigational Site
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • GSK Investigational Site
      • Elizabeth, New Jersey, United States, 07202
        • GSK Investigational Site
      • West Orange, New Jersey, United States, 07052
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • GSK Investigational Site
    • New York
      • 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
      • Westfield, New York, United States, 14787
        • GSK Investigational Site
      • Williamsville, New York, United States, 14221
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Gastonia, North Carolina, United States, 28054
        • GSK Investigational Site
      • Matthews, North Carolina, United States, 28105
        • GSK Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28677
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • GSK Investigational Site
      • Elyria, Ohio, United States, 44035
        • GSK Investigational Site
      • Garfield Heights, Ohio, United States, 44125
        • GSK Investigational Site
      • Kettering, Ohio, United States, 45429
        • GSK Investigational Site
      • Middleburg Heights, Ohio, United States, 44130
        • GSK Investigational Site
      • Sandusky, Ohio, United States, 44870
        • GSK Investigational Site
      • Toledo, Ohio, United States, 43614
        • GSK Investigational Site
      • Westlake, Ohio, United States, 44145
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97219
        • GSK Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • GSK Investigational Site
      • Danville, Pennsylvania, United States, 17822-4201
        • GSK Investigational Site
      • Doylestown, Pennsylvania, United States, 18901
        • GSK Investigational Site
      • Erie, Pennsylvania, United States, 16502
        • GSK Investigational Site
      • Jersey Shore, Pennsylvania, United States, 17740
        • GSK Investigational Site
      • Lewistown, Pennsylvania, United States, 17044
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • GSK Investigational Site
      • Philipsburg, Pennsylvania, United States, 16866
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15212
        • GSK Investigational Site
      • Port Matilda, Pennsylvania, United States, 16870
        • GSK Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • GSK Investigational Site
      • Scranton, Pennsylvania, United States, 18503
        • GSK Investigational Site
      • Scranton, Pennsylvania, United States, 18505
        • GSK Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • GSK Investigational Site
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • GSK Investigational Site
      • York, Pennsylvania, United States, 17403
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29425-6240
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • GSK Investigational Site
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • 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, 75231
        • GSK Investigational Site
      • Dallas, Texas, United States, 75226
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Harker Heights, Texas, United States, 76548
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Houston, Texas, United States, 77081
        • GSK Investigational Site
      • Plano, Texas, United States, 75024
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78217
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78244
        • GSK Investigational Site
      • Victoria, Texas, United States, 77901
        • GSK Investigational Site
    • Utah
      • Draper, Utah, United States, 84020
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Winchester, Virginia, United States, 22601
        • GSK Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98034
        • GSK Investigational Site
      • Olympia, Washington, United States, 98502
        • GSK Investigational Site
      • Renton, Washington, United States, 98057
        • GSK Investigational Site
      • Seattle, Washington, United States, 98104
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Spokane, Washington, United States, 99208
        • GSK Investigational Site
      • Spokane, Washington, United States, 99207
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
      • Walla Walla, Washington, United States, 99362
        • GSK Investigational Site
      • Wenatchee, Washington, United States, 98801
        • GSK Investigational Site
    • Wisconsin
      • 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:

  • Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.
  • Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.
  • Chronic coronary heart disease
  • At least one of the following:
  • At least 60 years old
  • Diabetes requiring treatment with medication
  • Low HDL cholesterol ("good cholesterol")
  • Currently smoke cigarettes or stopped smoking within the past 3 months
  • 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 arterial disease.

Exclusion Criteria:

  • Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.
  • 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 expected to result in death within the next 2 years (other than heart disease)
  • Severe asthma that is poorly controlled with medication
  • Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)
  • Previous severe allergic response to food, drink, insect stings, etc.
  • Drug or alcohol abuse within the past 6 months OR 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)
  • Participation in a study of an investigational medication within the past 30 days
  • Current participation in a study of an investigational device

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
Placebo Comparator: Placebo
Single daily oral tablet
Placebo administered in addition to standard therapy
Experimental: Darapladib
Single daily oral tablet
Lp-PLA2 inhibitor administered in addition to standard therapy

What is the study measuring?

Primary 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 Myocardial Infarction [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 4.25 years/average of 3.51 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 4.25 years/average of 3.51 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (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 4.25 years/average of 3.51 years)
CHD death=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. 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. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) 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 4.25 years/average of 3.51 years)
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 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 4.25 years/average of 3.51 years)
CHD death, acute MI, and prior MI are defined in the previous secondary 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 is found not to be caused by myocardial ischemia.
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Number of Participants With CV Death 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 4.25 years/average of 3.51 years)
CV death is defined as a 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.
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Number of Participants With First Occurrence of MI (Fatal/Non-fatal) 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 4.25 years/average of 3.51 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.
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) 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 4.25 years/average of 3.51 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).
From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 4.25 years/average of 3.51 years)
Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, 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 4.25 years/average of 3.51 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 4.25 years/average of 3.51 years)
Number of Participants With All-cause Mortality During the Time Period for Vital Status
Time Frame: From randomization until death or study completion (up to 4.49 years/average of 3.65 years)
The number of participants with all-cause mortality was assessed.
From randomization until death or study completion (up to 4.49 years/average of 3.65 years)

Collaborators and Investigators

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Sponsor

Publications and helpful links

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General Publications

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, 2008

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 17, 2013

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 28, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

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

  1. Informed Consent Form
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 100601
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: 100601
    Information 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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