Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) (ELIXA)

October 31, 2016 updated by: Sanofi

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

Primary Objective:

- To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina) compared to placebo in type 2 diabetic participants who recently experienced an acute coronary syndrome (ACS) event.

Secondary Objectives:

To demonstrate that when compared to placebo, lixisenatide can reduce:

composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure.
composite endpoint of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure.
urinary albumin excretion (based on the urinary albumin/creatinine ratio).

To assess the safety and tolerability of lixisenatide.

Study Overview

Status

Completed

Conditions

Acute Coronary Syndrome

Intervention / Treatment

Detailed Description

The estimated maximum study duration for the first randomized participant was approximately 204 weeks (± 14 days), with a median follow-up over all participants of approximately 91 weeks, broken down as follows:

placebo-run-in period: 7 days (+ 3 days)
double-blind study treatment period: 203 weeks (± 14 days) (with about a 37 months of recruitment period)
post-treatment follow-up period: 3 days (± 1 day)

All participants were followed from randomization until the end of study, which should occur when the last randomized participant had been followed for approximately 10 months. The actual end date of the study was "event driven" and the study end when there were approximately 844 positively-adjudicated primary cardiovascular outcome events.

Study Type

Interventional

Enrollment (Actual)

6068

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

Argentina
- - Adrogue, Argentina, B1846DSK
    - Investigational Site Number 032028
  - Bahia Blanca, Argentina, B8000AKK
    - Investigational Site Number 032030
  - Bahia Blanca, Argentina, B8000FTD
    - Investigational Site Number 032043
  - Bahia Blanca, Argentina, B8001HXM
    - Investigational Site Number 032054
  - Caba, Argentina, 1120
    - Investigational Site Number 032066
  - Caba, Argentina, 1440
    - Investigational Site Number 032049
  - Caba, Argentina, C1181ACL
    - Investigational Site Number 032056
  - Caba, Argentina, C1425AGC
    - Investigational Site Number 032003
  - Capital Federal, Argentina, C1056ABJ
    - Investigational Site Number 032017
  - Capital Federal, Argentina, C1179AAB
    - Investigational Site Number 032009
  - Cipolletti, Argentina, 8324
    - Investigational Site Number 032050
  - Ciudad Autonoma De Bs.As, Argentina, 1428
    - Investigational Site Number 032052
  - Cordoba, Argentina, X50009BSN
    - Investigational Site Number 032011
  - Cordoba, Argentina, X5000AAW
    - Investigational Site Number 032022
  - Cordoba, Argentina, X5000AAX
    - Investigational Site Number 032037
  - Coronel Suarez, Argentina, B7540GHD
    - Investigational Site Number 032020
  - Corrientes, Argentina, 3400
    - Investigational Site Number 032004
  - Corrientes, Argentina, W3410AVV
    - Investigational Site Number 032018
  - Córdoba, Argentina, 5000
    - Investigational Site Number 032015
  - Godoy Cruz, Argentina, M5501ARP
    - Investigational Site Number 032005
  - Haedo, Argentina, 1706
    - Investigational Site Number 032042
  - Junin, Argentina, B6000BHA
    - Investigational Site Number 032019
  - La Plata, Argentina, 1900
    - Investigational Site Number 032063
  - Lanus, Argentina, 1824
    - Investigational Site Number 032040
  - Mar Del Plata, Argentina, B7600
    - Investigational Site Number 032036
  - Mar Del Plata, Argentina, C7600CBM
    - Investigational Site Number 032039
  - Mendoza, Argentina, 5500
    - Investigational Site Number 032058
  - Moron, Argentina, 1708
    - Investigational Site Number 032038
  - Parana, Argentina, E3100BBJ
    - Investigational Site Number 032002
  - Qilmes, Argentina, b1878dkf
    - Investigational Site Number 032023
  - Rafaela, Argentina, S2300MMA
    - Investigational Site Number 032047
  - Ramos Mejia, Argentina, 1704
    - Investigational Site Number 032024
  - Resistencia, Argentina, H3500CDM
    - Investigational Site Number 032006
  - Rosario, Argentina, 2000CVD
    - Investigational Site Number 032012
  - Rosario, Argentina, S2000DSR
    - Investigational Site Number 032027
  - Salta, Argentina, 4400
    - Investigational Site Number 032055
  - Salta, Argentina, 4400
    - Investigational Site Number 032065
  - San Miguel De Tucuman, Argentina, 4000
    - Investigational Site Number 032051
  - San Miguel De Tucuman, Argentina, T4000ICL
    - Investigational Site Number 032008
  - San Nicolas, Argentina, B2900DMH
    - Investigational Site Number 032033
  - Santa Fe, Argentina, S3000AZG
    - Investigational Site Number 032045
  - Santa Fe, Argentina, S3000FWO
    - Investigational Site Number 032035
  - Santa Rosa, Argentina, L6300DSD
    - Investigational Site Number 032062
  - Venado Tuerto, Argentina, S2600KUE
    - Investigational Site Number 032034
  - Villa Maria, Argentina, X5900JKA
    - Investigational Site Number 032046
  - Zarate, Argentina, B2800DGH
    - Investigational Site Number 032029
Australia
- - Epping, Australia, 3076
    - Investigational Site Number 036015
  - Fremantle, Australia, 6160
    - Investigational Site Number 036001
  - Geelong, Australia, 3220
    - Investigational Site Number 036009
  - Perth, Australia, 6000
    - Investigational Site Number 036011
  - St Leonards, Australia, 2065
    - Investigational Site Number 036005
  - Townsville, Australia, 4810
    - Investigational Site Number 036016
Austria
- - Graz, Austria, 8036
    - Investigational Site Number 040002
  - Wien, Austria, 1160
    - Investigational Site Number 040001
Belarus
- - Minsk, Belarus, 220116
    - Investigational Site Number 112001
  - Minsk, Belarus, 220036
    - Investigational Site Number 112002
  - Minsk, Belarus, 220096
    - Investigational Site Number 112003
Belgium
- - Bruxelles, Belgium, 1200
    - Investigational Site Number 056001
  - Leuven, Belgium, 3000
    - Investigational Site Number 056003
Brazil
- - Belem, Brazil, 66087-660
    - Investigational Site Number 076024
  - Belo Horizonte, Brazil, 30150-221
    - Investigational Site Number 076006
  - Belo Horizonte, Brazil, 30150-221
    - Investigational Site Number 076012
  - Brasilia, Brazil, 70310-500
    - Investigational Site Number 076021
  - Campinas, Brazil, 13015-001
    - Investigational Site Number 076002
  - Curitiba, Brazil, 80730-150
    - Investigational Site Number 076019
  - Fortaleza, Brazil, 60430-370
    - Investigational Site Number 076004
  - Fortaleza, Brazil, 60115-282
    - Investigational Site Number 076003
  - Fortaleza, Brazil, 60170-320
    - Investigational Site Number 076018
  - Goiania, Brazil, 74823470
    - Investigational Site Number 076023
  - Marilia, Brazil, 17515-240
    - Investigational Site Number 076014
  - Passo Fundo, Brazil, 99010-180
    - Investigational Site Number 076015
  - Porto Alegre, Brazil, 90020-090
    - Investigational Site Number 076008
  - Porto Alegre, Brazil, 90035-001
    - Investigational Site Number 076013
  - Porto Alegre, Brazil, 90620-001
    - Investigational Site Number 076026
  - Recife, Brazil, 52051-380
    - Investigational Site Number 076025
  - Salvador, Brazil, 40050-410
    - Investigational Site Number 076020
  - Sao Paulo, Brazil, 01323-001
    - Investigational Site Number 076016
  - Sao Paulo, Brazil, 04012-180
    - Investigational Site Number 076010
  - Sao Paulo, Brazil, 04024-002
    - Investigational Site Number 076001
  - Sao Paulo, Brazil, 05403-000
    - Investigational Site Number 076005
  - Uberlandia, Brazil, 38400-368
    - Investigational Site Number 076007
Bulgaria
- - Byala, Bulgaria, 7100
    - Investigational Site Number 100002
  - Gabrovo, Bulgaria, 5300
    - Investigational Site Number 100011
  - Kazanluk, Bulgaria, 6100
    - Investigational Site Number 100001
  - Lovech, Bulgaria, 5500
    - Investigational Site Number 100006
  - Pleven, Bulgaria, 5800
    - Investigational Site Number 100004
  - Plovdiv, Bulgaria, 4002
    - Investigational Site Number 100003
  - Plovdiv, Bulgaria, 4002
    - Investigational Site Number 100007
  - Sandanski, Bulgaria, 2800
    - Investigational Site Number 100016
  - Sofia, Bulgaria, 1606
    - Investigational Site Number 100010
  - Sofia, Bulgaria, 1618
    - Investigational Site Number 100015
  - Varna, Bulgaria, 9000
    - Investigational Site Number 100005
Canada
- - Calgary, Canada, T2N 4N1
    - Investigational Site Number 124024
  - Cambridge, Canada, N1R 7Z6
    - Investigational Site Number 124016
  - Edmonton, Canada, T6G 2B7
    - Investigational Site Number 124026
  - Laval, Canada, H7T 2P5
    - Investigational Site Number 124001
  - Montreal, Canada, H1T 1C8
    - Investigational Site Number 124021
  - Montreal, Canada, H3Z 1E5
    - Investigational Site Number 124006
  - Oshawa, Canada, L1J 2J9
    - Investigational Site Number 124027
  - Quebec, Canada, G1V 4G5
    - Investigational Site Number 124025
  - Red Deer, Canada, T4N 6V7
    - Investigational Site Number 124028
  - Sarnia, Canada, N7T 4R9
    - Investigational Site Number 124007
  - St-Marc-Des-Carrieres, Canada, G0A 4B0
    - Investigational Site Number 124003
  - Sudbury, Canada, P3C 5K7
    - Investigational Site Number 124005
  - Thetford Mines, Canada, G6G 2V4
    - Investigational Site Number 124002
Chile
- - Antofagasta, Chile, 1270001
    - Investigational Site Number 152024
  - Concepcion, Chile, 4070038
    - Investigational Site Number 152023
  - Osorno, Chile, 5311092
    - Investigational Site Number 152041
  - Puerto Montt, Chile, 5480000
    - Investigational Site Number 152040
  - Punta Arenas, Chile, 6210005
    - Investigational Site Number 152038
  - San Felipe, Chile, 2172972
    - Investigational Site Number 152036
  - Santiago, Chile, 7500710
    - Investigational Site Number 152001
  - Santiago, Chile, 7650018
    - Investigational Site Number 152019
  - Santiago, Chile, 285-1950
    - Investigational Site Number 152035
  - Santiago, Chile, 7500010
    - Investigational Site Number 152020
  - Santiago, Chile, 7500503
    - Investigational Site Number 152028
  - Santiago, Chile, 7500520
    - Investigational Site Number 152031
  - Santiago, Chile, 7500710
    - Investigational Site Number 152034
  - Santiago, Chile, 7591047
    - Investigational Site Number 152008
  - Santiago, Chile, 7591047
    - Investigational Site Number 152013
  - Santiago, Chile, 7980378
    - Investigational Site Number 152018
  - Santiago, Chile, 80004005
    - Investigational Site Number 152042
  - Santiago, Chile, 8053095
    - Investigational Site Number 152015
  - Santiago, Chile, 8350595
    - Investigational Site Number 152004
  - Santiago, Chile, 838-0456
    - Investigational Site Number 152029
  - Santiago, Chile, 8380456
    - Investigational Site Number 152022
  - Santiago, Chile, 890-0085
    - Investigational Site Number 152011
  - Talca, Chile, 9999
    - Investigational Site Number 152025
  - Temuco, Chile, 4813299
    - Investigational Site Number 152003
  - Temuco, Chile, 4781173
    - Investigational Site Number 152014
  - Valdivia, Chile, 5090146
    - Investigational Site Number 152037
  - Valparaíso, Chile, 234-0207
    - Investigational Site Number 152032
  - Vina Del Mar, Chile
    - Investigational Site Number 152002
  - Viña Del Mar, Chile, 2570017
    - Investigational Site Number 152010
China
- - Beijing, China, 100853
    - Investigational Site Number 156001
  - Beijing, China, 100029
    - Investigational Site Number 156016
  - Beijing, China, 100029
    - Investigational Site Number 156034
  - Beijing, China, 100034
    - Investigational Site Number 156024
  - Beijing, China, 100037
    - Investigational Site Number 156028
  - Beijing, China, 100088
    - Investigational Site Number 156014
  - Beijing, China, 100730
    - Investigational Site Number 156005
  - Beijing, China, 100730
    - Investigational Site Number 156006
  - Dalian, China, 116011
    - Investigational Site Number 156008
  - Guangzhou, China, 510080
    - Investigational Site Number 156020
  - Jinan, China, 250012
    - Investigational Site Number 156023
  - Jinan, China, 250013
    - Investigational Site Number 156015
  - Nanjing, China, 210008
    - Investigational Site Number 156009
  - Shanghai, China, 200003
    - Investigational Site Number 156013
  - Shanghai, China, 200080
    - Investigational Site Number 156019
  - Shenyang, China, 110004
    - Investigational Site Number 156032
  - Shenyang, China, 110016
    - Investigational Site Number 156022
  - Suzhou, China, 215006
    - Investigational Site Number 156004
  - Urumchi, China, 830054
    - Investigational Site Number 156033
Colombia
- - Armenia, Colombia
    - Investigational Site Number 170025
  - Barranquilla, Colombia
    - Investigational Site Number 170009
  - Barranquilla, Colombia
    - Investigational Site Number 170010
  - Bogota, Colombia
    - Investigational Site Number 170012
  - Bogota, Colombia
    - Investigational Site Number 170005
  - Bogota, Colombia
    - Investigational Site Number 170002
  - Bogota, Colombia
    - Investigational Site Number 170014
  - Bogota, Colombia
    - Investigational Site Number 170022
  - Bucaramanga, Colombia
    - Investigational Site Number 170004
  - Cali, Colombia
    - Investigational Site Number 170017
  - Cali, Colombia
    - Investigational Site Number 170024
  - Cartagena, Colombia
    - Investigational Site Number 170013
  - Espinal - Tolima, Colombia
    - Investigational Site Number 170026
  - Floridablanca, Colombia
    - Investigational Site Number 170007
  - Floridablanca, Colombia
    - Investigational Site Number 170008
  - Manizales, Colombia
    - Investigational Site Number 170019
  - Medellin, Colombia
    - Investigational Site Number 170003
  - Medellin, Colombia
    - Investigational Site Number 170020
  - Pereira, Colombia
    - Investigational Site Number 170021
Denmark
- - Aarhus, Denmark, 8000
    - Investigational Site Number 208003
  - Aarhus C, Denmark, 8000
    - Investigational Site Number 208009
  - Esbjerg, Denmark, 6700
    - Investigational Site Number 208011
  - Farsø, Denmark, 9640
    - Investigational Site Number 208004
  - Hellerup, Denmark, 2900
    - Investigational Site Number 208002
  - Herlev, Denmark, 2730
    - Investigational Site Number 208010
  - Hillerød, Denmark, 3400
    - Investigational Site Number 208008
  - Hvidovre, Denmark, 2650
    - Investigational Site Number 208006
  - København Nv, Denmark, 2400
    - Investigational Site Number 208001
  - København S, Denmark, 2300
    - Investigational Site Number 208005
  - København Ø, Denmark, 2100
    - Investigational Site Number 208007
Ecuador
- - Guayaquil, Ecuador, EC090112
    - Investigational Site Number 218001
  - Guayaquil, Ecuador, EC09112
    - Investigational Site Number 218005
  - Quito, Ecuador, EC090112
    - Investigational Site Number 218002
Egypt
- - Alexandria, Egypt
    - Investigational Site Number 818002
  - Cairo, Egypt
    - Investigational Site Number 818001
Estonia
- - Tallinn, Estonia, 13419
    - Investigational Site Number 233001
  - Tallinn, Estonia, 10138
    - Investigational Site Number 233004
  - Tallinn, Estonia, 13419
    - Investigational Site Number 233003
  - Tallinn, Estonia, 13415
    - Investigational Site Number 233002
  - Tartu, Estonia, 50406
    - Investigational Site Number 233005
  - Viljandimaa, Estonia, 71024
    - Investigational Site Number 233006
Finland
- - Jyväskylä, Finland, 40620
    - Investigational Site Number 246005
  - Rauma, Finland, 26100
    - Investigational Site Number 246003
  - Tampere, Finland, 33520
    - Investigational Site Number 246010
  - Turku, Finland, FIN-20520
    - Investigational Site Number 246009
  - Valkeakoski, Finland, 37600
    - Investigational Site Number 246007
  - Vantaa, Finland, 01600
    - Investigational Site Number 246012
France
- - Brest Cedex, France, 29610
    - Investigational Site Number 250008
  - Corbeil Essonnes, France, 91109
    - Investigational Site Number 250002
  - Nantes, France, 44093
    - Investigational Site Number 250005
  - Nimes, France, 30029
    - Investigational Site Number 250014
  - Paris Cedex 15, France, 75908
    - Investigational Site Number 250007
  - Pessac, France, 33600
    - Investigational Site Number 250011
  - Poitiers Cedex, France, 86021
    - Investigational Site Number 250012
  - Rennes, France, 35700
    - Investigational Site Number 250006
  - Toulouse Cedex 4, France, 31403
    - Investigational Site Number 250001
Georgia
- - Batumi, Georgia
    - Investigational Site Number 268003
  - Kutaisi, Georgia
    - Investigational Site Number 268004
  - Tbilisi, Georgia
    - Investigational Site Number 268001
  - Tbilisi, Georgia
    - Investigational Site Number 268002
Germany
- - Berlin, Germany, 13347
    - Investigational Site Number 276003
  - Bochum, Germany, 44787
    - Investigational Site Number 276022
  - Chemnitz, Germany, 09111
    - Investigational Site Number 276005
  - Dresden, Germany, 01067
    - Investigational Site Number 276021
  - Dresden, Germany, 01099
    - Investigational Site Number 276024
  - Elsterwerda, Germany, 04910
    - Investigational Site Number 276007
  - Frankfurt A.M., Germany, 60596
    - Investigational Site Number 276018
  - Frankfurt Am Main, Germany, 60389
    - Investigational Site Number 276011
  - Görlitz, Germany, 02826
    - Investigational Site Number 276017
  - Haßloch, Germany, 67454
    - Investigational Site Number 276025
  - Heidelberg, Germany, 69120
    - Investigational Site Number 276009
  - Leipzig, Germany, 04103
    - Investigational Site Number 276019
  - Magdeburg, Germany, 39104
    - Investigational Site Number 276020
  - Mühldorf Am Inn, Germany, 84453
    - Investigational Site Number 276028
  - Pirna, Germany, 01796
    - Investigational Site Number 276014
  - Pohlheim, Germany, 35415
    - Investigational Site Number 276016
  - Rotenburg An Der Fulda, Germany, 36199
    - Investigational Site Number 276026
Guatemala
- - Guatemala, Guatemala, 01014
    - Investigational Site Number 320001
  - Guatemala, Guatemala, 01010
    - Investigational Site Number 320004
  - Guatemala, Guatemala, 01010
    - Investigational Site Number 320006
  - Guatemala, Guatemala, 01010
    - Investigational Site Number 320012
  - Guatemala, Guatemala, 01010
    - Investigational Site Number 320014
  - Guatemala, Guatemala, 01014
    - Investigational Site Number 320002
  - Guatemala, Guatemala, 01014
    - Investigational Site Number 320007
  - Guatemala, Guatemala, 01014
    - Investigational Site Number 320008
  - Guatemala, Guatemala, 01015
    - Investigational Site Number 320011
  - Quetzaltenango, Guatemala, 09001
    - Investigational Site Number 320015
India
- - Ahmedabad, India, 380052
    - Investigational Site Number 356019
  - Bangalore, India, 560043
    - Investigational Site Number 356002
  - Bangalore, India, 560092
    - Investigational Site Number 356010
  - Bangalore, India, 562114
    - Investigational Site Number 356026
  - Belgaum, India, 590001
    - Investigational Site Number 356024
  - Chandigarh, India, 160062
    - Investigational Site Number 356012
  - Cochin, India, 682026
    - Investigational Site Number 356016
  - Gurgaon, India, 122002
    - Investigational Site Number 356022
  - Hubli, India, 580021
    - Investigational Site Number 356029
  - Hyderabad, India, 500063
    - Investigational Site Number 356020
  - Jaipur, India, 302001
    - Investigational Site Number 356031
  - Kolkata, India
    - Investigational Site Number 356004
  - Lucknow, India, 226003
    - Investigational Site Number 356015
  - Lucknow, India
    - Investigational Site Number 356014
  - Ludhiana, India, 141001
    - Investigational Site Number 356009
  - Madurai, India
    - Investigational Site Number 356025
  - Mangalore, India, 575002
    - Investigational Site Number 356032
  - Manipal, India, 576104
    - Investigational Site Number 356018
  - Mysore, India, 570020
    - Investigational Site Number 356023
  - Nagpur, India, 440010
    - Investigational Site Number 356027
  - Nagpur, India
    - Investigational Site Number 356006
  - Nashik, India, 422005
    - Investigational Site Number 356034
  - Nasik, India, 422002
    - Investigational Site Number 356030
  - New Delhi, India, 110017
    - Investigational Site Number 356013
  - New Delhi, India, 122001
    - Investigational Site Number 356017
  - Pune, India, 411001
    - Investigational Site Number 356021
  - Pune, India, 411019
    - Investigational Site Number 356028
Israel
- - Afula, Israel, 18101
    - Investigational Site Number 376010
  - Givatayim, Israel, 53583
    - Investigational Site Number 376006
  - Haifa, Israel, 31096
    - Investigational Site Number 376002
  - Haifa, Israel, 35251
    - Investigational Site Number 376008
  - Holon, Israel, 58100
    - Investigational Site Number 376001
  - Jerusalem, Israel, 91120
    - Investigational Site Number 376012
  - Nahariya, Israel, 22100
    - Investigational Site Number 376011
  - Safed, Israel, 13100
    - Investigational Site Number 376005
  - Tel Aviv, Israel, 64239
    - Investigational Site Number 376004
  - Tel Hashomer, Israel, 52621
    - Investigational Site Number 376003
  - Tzrifin, Israel, 70300
    - Investigational Site Number 376009
Italy
- - Carpi, Italy, 41012
    - Investigational Site Number 380024
  - Chieri, Italy, 10023
    - Investigational Site Number 380004
  - Chieti, Italy, 66013
    - Investigational Site Number 380002
  - Fermo, Italy, 63023
    - Investigational Site Number 380006
  - Firenze, Italy, 50141
    - Investigational Site Number 380010
  - Genova, Italy, 16011
    - Investigational Site Number 380009
  - Messina, Italy, 98124
    - Investigational Site Number 380016
  - Milano, Italy, 20122
    - Investigational Site Number 380023
  - Milano, Italy, 20132
    - Investigational Site Number 380011
  - Milano, Italy, 20142
    - Investigational Site Number 380012
  - Napoli, Italy, 80131
    - Investigational Site Number 380014
  - Novara, Italy, 28100
    - Investigational Site Number 380019
  - Palermo, Italy, 90127
    - Investigational Site Number 380005
  - Pisa, Italy, 56124
    - Investigational Site Number 380001
  - Roma, Italy, 00128
    - Investigational Site Number 380013
  - Rozzano, Italy, 20089
    - Investigational Site Number 380020
Japan
- - Chuo-Ku, Japan
    - Investigational Site Number 392011
  - Fuchu-Shi, Japan
    - Investigational Site Number 392015
  - Fujisawa-Shi, Japan
    - Investigational Site Number 392012
  - Hachioji-Shi, Japan
    - Investigational Site Number 392025
  - Hakusan-Shi, Japan
    - Investigational Site Number 392027
  - Hamamatsu-Shi, Japan
    - Investigational Site Number 392005
  - Hitachi-Shi, Japan
    - Investigational Site Number 392022
  - Itabashi-Ku, Japan
    - Investigational Site Number 392003
  - Itabashi-Ku, Japan
    - Investigational Site Number 392017
  - Kawanishi-Shi, Japan
    - Investigational Site Number 392019
  - Kobe-Shi, Japan
    - Investigational Site Number 392013
  - Matsuyama-Shi, Japan
    - Investigational Site Number 392007
  - Matsuyama-Shi, Japan
    - Investigational Site Number 392008
  - Nagasaki-Shi, Japan
    - Investigational Site Number 392009
  - Noda-Shi, Japan
    - Investigational Site Number 392002
  - Osaka-Shi, Japan
    - Investigational Site Number 392021
  - Osaka-Shi, Japan
    - Investigational Site Number 392020
  - Sapporo-Shi, Japan
    - Investigational Site Number 392001
  - Sapporo-Shi, Japan
    - Investigational Site Number 392010
  - Setagaya-Ku, Japan
    - Investigational Site Number 392024
  - Shinagawa-Ku, Japan
    - Investigational Site Number 392004
  - Shirakawa-Shi, Japan
    - Investigational Site Number 392014
  - Suita-Shi, Japan
    - Investigational Site Number 392018
  - Tachikawa-Shi, Japan
    - Investigational Site Number 392016
  - Takasaki-Shi, Japan
    - Investigational Site Number 392023
Korea, Republic of
- - Bucheon, Korea, Republic of, 420-767
    - Investigational Site Number 410012
  - Daegu, Korea, Republic of, 705-717
    - Investigational Site Number 410006
  - Gwangju, Korea, Republic of, 501-757
    - Investigational Site Number 410009
  - Incheon, Korea, Republic of, 400-711
    - Investigational Site Number 410008
  - Incheon, Korea, Republic of, 405-760
    - Investigational Site Number 410001
  - Seongnam, Korea, Republic of, 463-707
    - Investigational Site Number 410004
  - Seoul, Korea, Republic of, 110-744
    - Investigational Site Number 410014
  - Seoul, Korea, Republic of, 134-727
    - Investigational Site Number 410013
  - Seoul, Korea, Republic of, 135-720
    - Investigational Site Number 410002
  - Seoul, Korea, Republic of, 152-703
    - Investigational Site Number 410011
  - Seoul, Korea, Republic of, 156-755
    - Investigational Site Number 410010
  - Wonju, Korea, Republic of, 220-701
    - Investigational Site Number 410007
Latvia
- - Cesis, Latvia, LV-4101
    - Investigational Site Number 428005
  - Daugavpils, Latvia, LV-5417
    - Investigational Site Number 428001
  - Liepaja, Latvia, LV-3414
    - Investigational Site Number 428002
  - Riga, Latvia, LV-1002
    - Investigational Site Number 428003
  - Riga, Latvia, LV-1011
    - Investigational Site Number 428007
  - Riga, Latvia, LV-1038
    - Investigational Site Number 428004
  - Sigulda, Latvia, LV-2150
    - Investigational Site Number 428006
Lithuania
- - Kaunas, Lithuania, LT-50009
    - Investigational Site Number 440002
  - Kaunas, Lithuania, LT-49456
    - Investigational Site Number 440003
  - Klaipeda, Lithuania, LT-91131
    - Investigational Site Number 440004
  - Klaipeda, Lithuania, LT-92304
    - Investigational Site Number 440006
  - Panevezys, Lithuania, LT-37355
    - Investigational Site Number 440005
  - Vilnius, Lithuania, LT-08661
    - Investigational Site Number 440001
Mexico
- - Acapulco, Mexico, 39670
    - Investigational Site Number 484011
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484008
  - Aguascalientes, Mexico, 20230
    - Investigational Site Number 484033
  - Chihuahua, Mexico, 31000
    - Investigational Site Number 484016
  - Ciudad Madero, Mexico, 89440
    - Investigational Site Number 484023
  - Durango, Mexico, 34000
    - Investigational Site Number 484007
  - Durango, Mexico, 34080
    - Investigational Site Number 484001
  - Durango, Mexico, 34080
    - Investigational Site Number 484041
  - Guadalajara, Mexico, 44150
    - Investigational Site Number 484032
  - Guadalajara, Mexico, 44160
    - Investigational Site Number 484034
  - Guadalajara, Mexico, 44210
    - Investigational Site Number 484014
  - Guadalajara, Mexico, 44210
    - Investigational Site Number 484028
  - Guadalajara, Mexico, 44670
    - Investigational Site Number 484021
  - Guadalajara, Mexico, 44680
    - Investigational Site Number 484006
  - Guadalajara, Mexico, 45200
    - Investigational Site Number 484018
  - Leon, Mexico, 37150
    - Investigational Site Number 484024
  - Mexico City, Mexico, 06470
    - Investigational Site Number 484026
  - Mexico City, Mexico, 07300
    - Investigational Site Number 484022
  - Mexico City, Mexico, 14000
    - Investigational Site Number 484013
  - Monterrey, Mexico, 64460
    - Investigational Site Number 484005
  - Monterrey, Mexico, 64460
    - Investigational Site Number 484002
  - Monterrey, Mexico, 64020
    - Investigational Site Number 484003
  - Monterrey, Mexico, 64060
    - Investigational Site Number 484025
  - Monterrey, Mexico, 64620
    - Investigational Site Number 484004
  - Morelia, Mexico, 58260
    - Investigational Site Number 484035
  - San Luis Potosi, Mexico, 78200
    - Investigational Site Number 484020
  - Tlalnepantla, Mexico, 54055
    - Investigational Site Number 484017
  - Xalapa, Mexico, 91020
    - Investigational Site Number 484031
Netherlands
- - Alkmaar, Netherlands, 1815 JD
    - Investigational Site Number 528005
  - Den Haag, Netherlands, 2597 AX
    - Investigational Site Number 528007
  - Deventer, Netherlands, 7416 SE
    - Investigational Site Number 528008
  - Hoorn, Netherlands, 1625 HV
    - Investigational Site Number 528004
  - Rotterdam, Netherlands, 3045 PM
    - Investigational Site Number 528001
  - Tilburg, Netherlands, 5022 GC
    - Investigational Site Number 528003
  - Venlo, Netherlands, 5912 BL
    - Investigational Site Number 528006
Norway
- - Bodø, Norway, 8092
    - Investigational Site Number 578003
  - Haugesund, Norway, 5528
    - Investigational Site Number 578002
  - Stavanger, Norway, 4095
    - Investigational Site Number 578001
Panama
- - Cuidad De Panama, Panama
    - Investigational Site Number 591001
  - Cuidad De Panama, Panama
    - Investigational Site Number 591003
  - La Chorrera, Panama
    - Investigational Site Number 591004
  - Penonome, Panama
    - Investigational Site Number 591002
Peru
- - Arequipa, Peru, 5154
    - Investigational Site Number 604007
  - Callao, Peru, CALLAO 2
    - Investigational Site Number 604014
  - Lima, Peru, 051
    - Investigational Site Number 604011
  - Lima, Peru, 27
    - Investigational Site Number 604002
  - Lima, Peru, 051
    - Investigational Site Number 604019
  - Lima, Peru, 11
    - Investigational Site Number 604013
  - Lima, Peru, 12
    - Investigational Site Number 604010
  - Lima, Peru, 27
    - Investigational Site Number 604006
  - Lima, Peru, 511
    - Investigational Site Number 604015
  - Lima, Peru, 511
    - Investigational Site Number 604016
  - Lima, Peru, LIMA 01
    - Investigational Site Number 604017
  - Lima, Peru, LIMA 11
    - Investigational Site Number 604018
  - Lima, Peru, LIMA 14
    - Investigational Site Number 604005
  - Lima, Peru, LIMA 27
    - Investigational Site Number 604009
  - Lima, Peru, LIMA 31
    - Investigational Site Number 604001
Philippines
- - Cavite, Philippines
    - Investigational Site Number 608006
  - Iligan City, Lanao Del Norte, Philippines, 9200
    - Investigational Site Number 608009
  - Makati City, Philippines
    - Investigational Site Number 608003
  - Manila, Philippines, 1008
    - Investigational Site Number 608001
  - Manila, Philippines
    - Investigational Site Number 608007
  - Marikina City, Philippines, 1800
    - Investigational Site Number 608005
  - Pasay City, Philippines, 1300
    - Investigational Site Number 608002
  - Quezon City, Philippines, 1109
    - Investigational Site Number 608008
Poland
- - ?ód?, Poland, 91-087
    - Investigational Site Number 616005
  - Bialystok, Poland, 15-276
    - Investigational Site Number 616008
  - Bydgoszcz, Poland, 85-046
    - Investigational Site Number 616019
  - Czeladz, Poland, 41-250
    - Investigational Site Number 616012
  - Czestochowa, Poland, 42-217
    - Investigational Site Number 616007
  - Gdynia, Poland, 81-394
    - Investigational Site Number 616014
  - Gliwice, Poland, 44-100
    - Investigational Site Number 616013
  - Grodzisk Mazowiecki, Poland, 05-825
    - Investigational Site Number 616028
  - Katowice, Poland, 40-767
    - Investigational Site Number 616022
  - Krakow, Poland, 30-082
    - Investigational Site Number 616001
  - Krakow, Poland, 31-024
    - Investigational Site Number 616024
  - Leczyca, Poland, 99-100
    - Investigational Site Number 616029
  - Poland, Poland, 42-500
    - Investigational Site Number 616023
  - Pulawy, Poland, 24-100
    - Investigational Site Number 616021
  - Ruda Slaska, Poland, 41-706
    - Investigational Site Number 616006
  - Szczecin, Poland, 70-506
    - Investigational Site Number 616025
  - Warszawa, Poland, 00-685
    - Investigational Site Number 616032
  - Wroclaw, Poland, 50-088
    - Investigational Site Number 616020
  - Wroclaw, Poland, 50-981
    - Investigational Site Number 616011
  - Zgierz, Poland, 95-100
    - Investigational Site Number 616031
Portugal
- - Amadora, Portugal, 2720-276
    - Investigational Site Number 620005
  - Coimbra, Portugal, 3000-075
    - Investigational Site Number 620003
  - Lisboa, Portugal, 1349-019
    - Investigational Site Number 620001
  - Penafiel, Portugal, 4564-007
    - Investigational Site Number 620007
  - Porto, Portugal, 4200
    - Investigational Site Number 620006
Romania
- - Arad, Romania, 310158
    - Investigational Site Number 642029
  - Baia Mare, Romania, 430123
    - Investigational Site Number 642020
  - Braila, Romania, 810249
    - Investigational Site Number 642019
  - Brasov, Romania, 500365
    - Investigational Site Number 642003
  - Bucharest, Romania, 010825
    - Investigational Site Number 642034
  - Bucuresti, Romania, 020475
    - Investigational Site Number 642022
  - Bucuresti, Romania, 021392
    - Investigational Site Number 642001
  - Bucuresti, Romania, 050098
    - Investigational Site Number 642013
  - Cluj Napoca, Romania, 40001
    - Investigational Site Number 642026
  - Craiova, Romania, 200147
    - Investigational Site Number 642030
  - Craiova, Romania, 200642
    - Investigational Site Number 642015
  - Deva, Romania, 330084
    - Investigational Site Number 642007
  - Iasi, Romania, 700547
    - Investigational Site Number 642011
  - Iasi, Romania, 700732
    - Investigational Site Number 642010
  - Oradea, Romania, 410598
    - Investigational Site Number 642016
  - Pitesti, Romania, 110084
    - Investigational Site Number 642033
  - Ploiesti, Romania, 100097
    - Investigational Site Number 642002
  - Suceava, Romania, 720262
    - Investigational Site Number 642009
  - Targu Mures, Romania, 540099
    - Investigational Site Number 642014
  - Targu Mures, Romania, 540142
    - Investigational Site Number 642012
  - Timisoara, Romania, 300174
    - Investigational Site Number 642018
  - Timisoara, Romania, 300736
    - Investigational Site Number 642031
Russian Federation
- - Barnaul, Russian Federation, 656055
    - Investigational Site Number 643023
  - Kazan, Russian Federation, 420012
    - Investigational Site Number 643044
  - Kemerovo, Russian Federation, 650002
    - Investigational Site Number 643005
  - Kemerovo, Russian Federation, 650002
    - Investigational Site Number 643006
  - Krasnodar, Russian Federation, 350063
    - Investigational Site Number 643061
  - Krasnodar, Russian Federation, 350086
    - Investigational Site Number 643027
  - Moscow, Russian Federation, 101990
    - Investigational Site Number 643037
  - Moscow, Russian Federation, 101990
    - Investigational Site Number 643038
  - Moscow, Russian Federation, 105066
    - Investigational Site Number 643002
  - Moscow, Russian Federation, 117036
    - Investigational Site Number 643043
  - Moscow, Russian Federation, 117292
    - Investigational Site Number 643008
  - Moscow, Russian Federation, 117292
    - Investigational Site Number 643009
  - Moscow, Russian Federation, 117556
    - Investigational Site Number 643029
  - Moscow, Russian Federation, 119048
    - Investigational Site Number 643018
  - Moscow, Russian Federation, 119435
    - Investigational Site Number 643042
  - Moscow, Russian Federation, 121309
    - Investigational Site Number 643052
  - Moscow, Russian Federation, 121374
    - Investigational Site Number 643026
  - Moscow, Russian Federation, 121552
    - Investigational Site Number 643003
  - Moscow, Russian Federation, 125284
    - Investigational Site Number 643051
  - Moscow, Russian Federation, 127018
    - Investigational Site Number 643013
  - Moscow, Russian Federation, 127473
    - Investigational Site Number 643001
  - Moscow, Russian Federation, 127644
    - Investigational Site Number 643060
  - Moscow, Russian Federation, 129327
    - Investigational Site Number 643040
  - Nizhny Novgorod, Russian Federation, 603003
    - Investigational Site Number 643034
  - Novosibirsk, Russian Federation, 630047
    - Investigational Site Number 643054
  - Novosibirsk, Russian Federation, 630075
    - Investigational Site Number 643055
  - Omsk, Russian Federation, 644043
    - Investigational Site Number 643045
  - Penza, Russian Federation, 440026
    - Investigational Site Number 643030
  - Perm, Russian Federation, 614077
    - Investigational Site Number 643017
  - Perm, Russian Federation, 614097
    - Investigational Site Number 643049
  - Rostov-Na-Donu, Russian Federation, 344068
    - Investigational Site Number 643048
  - Ryazan, Russian Federation, 390026
    - Investigational Site Number 643047
  - Saint-Petersburg, Russian Federation, 194156
    - Investigational Site Number 643039
  - Saratov, Russian Federation, 410028
    - Investigational Site Number 643025
  - Saratov, Russian Federation, 410028
    - Investigational Site Number 643056
  - Saratov, Russian Federation, 410030
    - Investigational Site Number 643010
  - Saratov, Russian Federation, 410039
    - Investigational Site Number 643033
  - Saratov, Russian Federation, 410054
    - Investigational Site Number 643019
  - Smolensk, Russian Federation, 214018
    - Investigational Site Number 643014
  - St-Petersburg, Russian Federation, 190000
    - Investigational Site Number 643024
  - St-Petersburg, Russian Federation, 192242
    - Investigational Site Number 643031
  - St-Petersburg, Russian Federation, 193312
    - Investigational Site Number 643035
  - St-Petersburg, Russian Federation, 194044
    - Investigational Site Number 643022
  - St-Petersburg, Russian Federation, 194354
    - Investigational Site Number 643057
  - St-Petersburg, Russian Federation, 195257
    - Investigational Site Number 643041
  - St-Petersburg, Russian Federation, 197341
    - Investigational Site Number 643036
  - St-Petersburg, Russian Federation, 198013
    - Investigational Site Number 643011
  - St-Petersburg, Russian Federation, 199106
    - Investigational Site Number 643004
  - Tomsk, Russian Federation, 634012
    - Investigational Site Number 643028
  - Tver, Russian Federation, 170036
    - Investigational Site Number 643016
  - Tyumen, Russian Federation, 625023
    - Investigational Site Number 643012
  - Vladimir, Russian Federation, 600020
    - Investigational Site Number 643059
  - Voronezh, Russian Federation, 394065
    - Investigational Site Number 643058
  - Yaroslavl, Russian Federation, 150003
    - Investigational Site Number 643020
  - Yaroslavl, Russian Federation, 150030
    - Investigational Site Number 643062
Serbia
- - Belgrade, Serbia, 11000
    - Investigational Site Number 688002
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688003
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688006
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688008
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688010
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688004
  - Belgrade, Serbia, 11000
    - Investigational Site Number 688009
  - Belgrade, Serbia, 11040
    - Investigational Site Number 688001
  - Nis, Serbia, 18000
    - Investigational Site Number 688005
  - Nis, Serbia, 18000
    - Investigational Site Number 688007
South Africa
- - Alberton, South Africa, 1450
    - Investigational Site Number 710020
  - Cape Town, South Africa, 7405
    - Investigational Site Number 710017
  - Cape Town, South Africa, 7530
    - Investigational Site Number 710006
  - Cape Town, South Africa, 7764
    - Investigational Site Number 710010
  - Cape Town, South Africa, 7925
    - Investigational Site Number 710025
  - Chatsworth, South Africa, 4091
    - Investigational Site Number 710008
  - Durban, South Africa
    - Investigational Site Number 710011
  - George, South Africa, 6529
    - Investigational Site Number 710015
  - Kempton Park, South Africa, 1619
    - Investigational Site Number 710019
  - Paarl, South Africa, 7646
    - Investigational Site Number 710014
  - Parow, South Africa, 7500
    - Investigational Site Number 710023
  - Pretoria, South Africa, 0002
    - Investigational Site Number 710002
  - Pretoria, South Africa, 181
    - Investigational Site Number 710001
  - Richards Bay, South Africa, 3900
    - Investigational Site Number 710005
  - Somerset West, South Africa, 7130
    - Investigational Site Number 710007
  - Worcester, South Africa, 6850
    - Investigational Site Number 710004
Spain
- - Alcalá De Henares, Spain, 28805
    - Investigational Site Number 724005
  - Almería, Spain, 04120
    - Investigational Site Number 724016
  - Barakaldo, Spain, 48903
    - Investigational Site Number 724012
  - Barcelona, Spain, 08036
    - Investigational Site Number 724018
  - Bilbao, Spain, 48013
    - Investigational Site Number 724014
  - Cáceres, Spain, 10003
    - Investigational Site Number 724015
  - La Coruña, Spain, 15006
    - Investigational Site Number 724013
  - Lérida, Spain, 25198
    - Investigational Site Number 724008
  - Madrid, Spain, 28046
    - Investigational Site Number 724011
  - Murcia, Spain, 30120
    - Investigational Site Number 724017
  - Oviedo, Spain, 33006
    - Investigational Site Number 724022
  - Pontevedra, Spain, 36071
    - Investigational Site Number 724003
  - Sevilla, Spain, 41014
    - Investigational Site Number 724001
  - Valencia, Spain, 46010
    - Investigational Site Number 724020
  - Vigo, Spain, 36211
    - Investigational Site Number 724004
Sweden
- - Karlstad, Sweden, 651 85
    - Investigational Site Number 752012
  - Kristianstad, Sweden, 29185
    - Investigational Site Number 752011
  - Ljungby, Sweden, 341 82
    - Investigational Site Number 752006
  - Oskarshamn, Sweden, 572 28
    - Investigational Site Number 752009
  - Stockholm, Sweden, 118 83
    - Investigational Site Number 752004
  - Stockholm, Sweden, 182 88
    - Investigational Site Number 752007
  - Växjö, Sweden, 351 85
    - Investigational Site Number 752002
Switzerland
- - Lugano, Switzerland, 6900
    - Investigational Site Number 756003
Taiwan
- - Chia-Yi, Taiwan, 60002
    - Investigational Site Number 158005
  - Taichung, Taiwan, 402
    - Investigational Site Number 158004
  - Tainan Hsien, Taiwan, 710
    - Investigational Site Number 158006
  - Taipei, Taiwan, 112
    - Investigational Site Number 158001
  - Taipei, Taiwan, 100
    - Investigational Site Number 158002
  - Taipei, Taiwan, 220
    - Investigational Site Number 158008
  - Taipei 111, Taiwan, 111
    - Investigational Site Number 158007
  - Taipei Hsien, Taiwan, 23137
    - Investigational Site Number 158003
Tunisia
- - Sfax, Tunisia, 3029
    - Investigational Site Number 788003
  - Tunis, Tunisia, 1006
    - Investigational Site Number 788005
  - Tunis, Tunisia, 1007
    - Investigational Site Number 788004
  - Tunis, Tunisia, 1008
    - Investigational Site Number 788002
  - Tunis, Tunisia, 1027
    - Investigational Site Number 788001
Turkey
- - Ankara, Turkey, 06110
    - Investigational Site Number 792004
  - Ankara, Turkey, 06490
    - Investigational Site Number 792002
  - Ankara, Turkey
    - Investigational Site Number 792012
  - Capa / Istanbul, Turkey, 34390
    - Investigational Site Number 792001
  - Istanbul, Turkey, 34010
    - Investigational Site Number 792015
  - Istanbul, Turkey, 34034
    - Investigational Site Number 792008
  - Istanbul, Turkey, 34385
    - Investigational Site Number 792014
  - Izmir, Turkey, 35100
    - Investigational Site Number 792003
  - Izmir, Turkey, 35100
    - Investigational Site Number 792007
  - Mersin, Turkey, 33169
    - Investigational Site Number 792011
  - Samsun, Turkey, 55200
    - Investigational Site Number 792013
Ukraine
- - Chernivtsi, Ukraine, 58022
    - Investigational Site Number 804004
  - Dnepropetrovsk, Ukraine, 49023
    - Investigational Site Number 804006
  - Dnipropetrovsk, Ukraine, 49006
    - Investigational Site Number 804002
  - Kharkiv, Ukraine, 61176
    - Investigational Site Number 804010
  - Kharkov, Ukraine, 61022
    - Investigational Site Number 804009
  - Kiev, Ukraine, 02091
    - Investigational Site Number 804003
  - Kiev, Ukraine, 02660
    - Investigational Site Number 804011
  - Kyiv, Ukraine, 03680
    - Investigational Site Number 804012
  - Kyiv, Ukraine, 04114
    - Investigational Site Number 804013
  - Lviv, Ukraine, 79015
    - Investigational Site Number 804005
  - Odessa, Ukraine, 65025
    - Investigational Site Number 804007
  - Odessa, Ukraine, 65059
    - Investigational Site Number 804008
United Arab Emirates
- - Abu Dhabi, United Arab Emirates, 51900
    - Investigational Site Number 784001
  - Dubai, United Arab Emirates, 4545
    - Investigational Site Number 784002
United Kingdom
- - Antrim, United Kingdom, BT41 2RL
    - Investigational Site Number 826042
  - Ashton-Under-Lyne, United Kingdom, OL6 9RW
    - Investigational Site Number 826002
  - Barnstaple, United Kingdom, EX31 4JB
    - Investigational Site Number 826026
  - Bath, United Kingdom, BA1 3NG
    - Investigational Site Number 826017
  - Birmingham, United Kingdom, B9 5SS
    - Investigational Site Number 826034
  - Bolton, United Kingdom, BL1 4AL
    - Investigational Site Number 826052
  - Bradford, United Kingdom, BD5 0NA
    - Investigational Site Number 826005
  - Carmarthen, United Kingdom, SA31 2AF
    - Investigational Site Number 826048
  - Chester, United Kingdom, CH2 1UL
    - Investigational Site Number 826037
  - Dumfries, United Kingdom, DG1 4AP
    - Investigational Site Number 826011
  - East Kilbride, United Kingdom, G75 8RG
    - Investigational Site Number 826044
  - Edinburgh, United Kingdom, EH3 9YW
    - Investigational Site Number 826023
  - Glasgow, United Kingdom, G11 6NT
    - Investigational Site Number 826008
  - Harrogate, United Kingdom, HG2 7SX
    - Investigational Site Number 826010
  - Ipswich, United Kingdom, IP4 5PD
    - Investigational Site Number 826040
  - Larbert, United Kingdom, FK5 4WR
    - Investigational Site Number 826033
  - Liverpool, United Kingdom, L9 7AL
    - Investigational Site Number 826027
  - Londonderry, United Kingdom, BT47 6SB
    - Investigational Site Number 826039
  - Manchester, United Kingdom, M13 9WL
    - Investigational Site Number 826036
  - Manchester, United Kingdom, M23 9LT
    - Investigational Site Number 826021
  - Manchester, United Kingdom, M8 6RB
    - Investigational Site Number 826006
  - Norwich, United Kingdom, NR1 3SR
    - Investigational Site Number 826049
  - Nuneaton, United Kingdom, CV10 7DJ
    - Investigational Site Number 826020
  - Oldham, United Kingdom, OL1 2JH
    - Investigational Site Number 826009
  - Salford, United Kingdom, M6 8HD
    - Investigational Site Number 826007
  - Stoke-On-Trent, United Kingdom, ST4 6QG
    - Investigational Site Number 826045
  - Swansea, United Kingdom, SA6 6NL
    - Investigational Site Number 826038
  - Taunton, United Kingdom, TA1 5DA
    - Investigational Site Number 826018
  - Truro, United Kingdom, TR1 3LJ
    - Investigational Site Number 826016
  - Wolverhampton, United Kingdom, WV10 0QP
    - Investigational Site Number 826046
  - Yeovil, United Kingdom, BA21 4AT
    - Investigational Site Number 826019
United States
- Alabama
  - Birmingham, Alabama, United States, 35203
    - Investigational Site Number 840415
  - Foley, Alabama, United States, 36535
    - Investigational Site Number 840307
  - Mobile, Alabama, United States, 36604
    - Investigational Site Number 840692
  - Mobile, Alabama, United States, 36608
    - Investigational Site Number 840037
  - Mobile, Alabama, United States, 36609
    - Investigational Site Number 840210
  - Muscle Shoals, Alabama, United States, 35661
    - Investigational Site Number 840326
  - Toney, Alabama, United States, 35773
    - Investigational Site Number 840393
- Arizona
  - Mesa, Arizona, United States, 85206
    - Investigational Site Number 840656
  - Phoenix, Arizona, United States, 85012
    - Investigational Site Number 840506
  - Phoenix, Arizona, United States, 85020
    - Investigational Site Number 840520
  - Phoenix, Arizona, United States, 85032
    - Investigational Site Number 840322
  - Tempe, Arizona, United States, 85284
    - Investigational Site Number 840250
  - Tucson, Arizona, United States, 85723
    - Investigational Site Number 840042
- Arkansas
  - Hot Springs, Arkansas, United States, 71913
    - Investigational Site Number 840303
  - Jonesboro, Arkansas, United States, 72401
    - Investigational Site Number 840184
  - Little Rock, Arkansas, United States, 72204
    - Investigational Site Number 840361
  - Little Rock, Arkansas, United States, 72205
    - Investigational Site Number 840023
- California
  - Anaheim, California, United States, 92801
    - Investigational Site Number 840706
  - Anaheim, California, United States, 92804
    - Investigational Site Number 840497
  - Downey, California, United States, 90242
    - Investigational Site Number 840667
  - Fresno, California, United States, 93722
    - Investigational Site Number 840150
  - Hawthorne, California, United States, 90250
    - Investigational Site Number 840624
  - Inglewood, California, United States, 90301
    - Investigational Site Number 840623
  - Inglewood, California, United States, 90301
    - Investigational Site Number 840636
  - La Mesa, California, United States, 91942
    - Investigational Site Number 840455
  - Loma Linda, California, United States, 92354
    - Investigational Site Number 840240
  - Long Beach, California, United States, 90806
    - Investigational Site Number 840262
  - Long Beach, California, United States, 90813
    - Investigational Site Number 840606
  - Los Angeles, California, United States, 90024
    - Investigational Site Number 840694
  - Los Angeles, California, United States, 90033
    - Investigational Site Number 840431
  - Los Angeles, California, United States, 90073
    - Investigational Site Number 840135
  - Merced, California, United States, 95348
    - Investigational Site Number 840314
  - Mission Viejo, California, United States, 92691
    - Investigational Site Number 840290
  - National City, California, United States, 91950
    - Investigational Site Number 840592
  - Northridge, California, United States, 91328
    - Investigational Site Number 840275
  - Oakland, California, United States, 94609
    - Investigational Site Number 840654
  - Orange, California, United States, 92868
    - Investigational Site Number 840351
  - Orange, California, United States, 92868
    - Investigational Site Number 840689
  - Pomona, California, United States, 91767
    - Investigational Site Number 840582
  - Port Hueneme, California, United States, 93041
    - Investigational Site Number 840346
  - Roseville, California, United States, 95661
    - Investigational Site Number 840466
  - San Marino, California, United States, 91108
    - Investigational Site Number 840575
  - Santa Ana, California, United States, 82705
    - Investigational Site Number 840131
  - Santa Ana, California, United States, 92704
    - Investigational Site Number 840335
  - Simi Valley, California, United States, 93065
    - Investigational Site Number 840576
  - Sylmar, California, United States, 91342
    - Investigational Site Number 840414
  - Ventura, California, United States, 93003
    - Investigational Site Number 840395
  - Vista, California, United States, 92081-7832
    - Investigational Site Number 840206
  - Westlake Village, California, United States, 91361
    - Investigational Site Number 840480
  - Whittier, California, United States, 90602
    - Investigational Site Number 840350
- Colorado
  - Colorado Springs, Colorado, United States, 80910
    - Investigational Site Number 840093
- District of Columbia
  - Washington, District of Columbia, United States, 20060
    - Investigational Site Number 840631
  - Washington, District of Columbia, United States, 20422
    - Investigational Site Number 840044
- Florida
  - Clearwater, Florida, United States, 33755
    - Investigational Site Number 840281
  - Homosassa, Florida, United States, 34448
    - Investigational Site Number 840477
  - Miami, Florida, United States, 33135
    - Investigational Site Number 840261
  - Miami, Florida, United States, 33155
    - Investigational Site Number 840459
  - Oviedo, Florida, United States, 32765
    - Investigational Site Number 840432
  - Panama City, Florida, United States, 32401
    - Investigational Site Number 840318
  - St. Petersburg, Florida, United States, 33707
    - Investigational Site Number 840056
  - Wellington, Florida, United States, 33449
    - Investigational Site Number 840295
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Investigational Site Number 840066
  - Atlanta, Georgia, United States, 30322
    - Investigational Site Number 840446
  - Atlanta, Georgia, United States, 30322
    - Investigational Site Number 840487
  - Blue Ridge, Georgia, United States, 30513
    - Investigational Site Number 840578
  - Columbus, Georgia, United States, 31904-5245
    - Investigational Site Number 840534
  - Duluth, Georgia, United States, 30096
    - Investigational Site Number 840447
  - Duluth, Georgia, United States, 30096
    - Investigational Site Number 840499
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Investigational Site Number 840536
  - Pocatello, Idaho, United States, 83201
    - Investigational Site Number 840413
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Investigational Site Number 840519
  - Belleville, Illinois, United States, 62220
    - Investigational Site Number 840589
  - Chicago, Illinois, United States, 60415
    - Investigational Site Number 840107
  - Chicago, Illinois, United States, 60611
    - Investigational Site Number 840633
  - Chicago, Illinois, United States, 60612
    - Investigational Site Number 840663
  - Hines, Illinois, United States, 60141
    - Investigational Site Number 840212
  - Joliet, Illinois, United States, 60435
    - Investigational Site Number 840345
  - Peoria, Illinois, United States, 61602
    - Investigational Site Number 840681
- Indiana
  - Elwood, Indiana, United States, 46036
    - Investigational Site Number 840360
  - Gary, Indiana, United States, 46409
    - Investigational Site Number 840676
  - Hammond, Indiana, United States, 46320
    - Investigational Site Number 840657
  - Huntington, Indiana, United States, 46750
    - Investigational Site Number 840621
  - Indianapolis, Indiana, United States, 46202
    - Investigational Site Number 840702
- Kansas
  - Topeka, Kansas, United States, 66606
    - Investigational Site Number 840009
- Kentucky
  - Covington, Kentucky, United States, 41011
    - Investigational Site Number 840533
  - Madisonville, Kentucky, United States, 42431
    - Investigational Site Number 840251
  - Owensboro, Kentucky, United States, 42303
    - Investigational Site Number 840168
  - Pikeville, Kentucky, United States, 41501
    - Investigational Site Number 840449
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Investigational Site Number 840299
  - Hammond, Louisiana, United States, 70403
    - Investigational Site Number 840671
  - Metairie, Louisiana, United States, 70006
    - Investigational Site Number 840470
  - Shreveport, Louisiana, United States, 71130
    - Investigational Site Number 840178
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Investigational Site Number 840043
  - Catonsville, Maryland, United States, 21228
    - Investigational Site Number 840639
  - Rockville, Maryland, United States, 20852
    - Investigational Site Number 840430
  - Takoma Park, Maryland, United States, 20912
    - Investigational Site Number 840640
  - Towson, Maryland, United States, 21204
    - Investigational Site Number 840293
- Michigan
  - Alpena, Michigan, United States, 49707
    - Investigational Site Number 840019
  - Buckley, Michigan, United States, 49620
    - Investigational Site Number 840352
  - Chesterfield, Michigan, United States, 48047
    - Investigational Site Number 840555
  - Dearborn, Michigan, United States, 48124
    - Investigational Site Number 840411
  - Detroit, Michigan, United States, 48235
    - Investigational Site Number 840205
  - Flint, Michigan, United States, 48503
    - Investigational Site Number 840581
  - Kalamazoo, Michigan, United States, 49048
    - Investigational Site Number 840404
  - Southfield, Michigan, United States, 48075
    - Investigational Site Number 840312
  - Sterling Heights, Michigan, United States, 48310
    - Investigational Site Number 840484
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - Investigational Site Number 840219
  - Eagan, Minnesota, United States, 55122
    - Investigational Site Number 840199
- Mississippi
  - Biloxi, Mississippi, United States, 39531
    - Investigational Site Number 840196
- Missouri
  - Kansas City, Missouri, United States, 64111
    - Investigational Site Number 840445
  - Kansas City, Missouri, United States, 64128
    - Investigational Site Number 840008
  - St. Louis, Missouri, United States, 63122
    - Investigational Site Number 840091
  - St. Louis, Missouri, United States, 63128
    - Investigational Site Number 840046
  - St. Louis, Missouri, United States, 63131
    - Investigational Site Number 840678
  - St. Louis, Missouri, United States, 63141
    - Investigational Site Number 840400
- Montana
  - Kalispell, Montana, United States, 59901
    - Investigational Site Number 840337
- Nebraska
  - Lincoln, Nebraska, United States, 68521
    - Investigational Site Number 840509
  - Omaha, Nebraska, United States, 68131
    - Investigational Site Number 840007
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Investigational Site Number 840382
  - Las Vegas, Nevada, United States, 89102
    - Investigational Site Number 840680
  - Las Vegas, Nevada, United States, 89148
    - Investigational Site Number 840217
- New Jersey
  - Linden, New Jersey, United States
    - Investigational Site Number 840072
  - Ridgewood, New Jersey, United States, 07450
    - Investigational Site Number 840628
  - Somerset, New Jersey, United States, 08873
    - Investigational Site Number 840162
- New York
  - Albany, New York, United States, 12206
    - Investigational Site Number 840285
  - Jamaica, New York, United States, 11432
    - Investigational Site Number 840585
  - Mineola, New York, United States, 11501
    - Investigational Site Number 840348
  - Northport, New York, United States, 11768
    - Investigational Site Number 840119
  - Rosedale, New York, United States, 14221
    - Investigational Site Number 840696
- North Carolina
  - Asheville, North Carolina, United States, 28805
    - Investigational Site Number 840310
  - Calabash, North Carolina, United States, 28467
    - Investigational Site Number 840454
  - Charlotte, North Carolina, United States, 28203
    - Investigational Site Number 840672
  - Charlotte, North Carolina, United States, 28205
    - Investigational Site Number 840152
  - Elizabeth City, North Carolina, United States, 27909
    - Investigational Site Number 840344
  - Greensboro, North Carolina, United States, 27401
    - Investigational Site Number 840328
  - Greensboro, North Carolina, United States, 27405
    - Investigational Site Number 840513
  - Greenville, North Carolina, United States, 27858
    - Investigational Site Number 840504
  - Monroe, North Carolina, United States, 28110
    - Investigational Site Number 840642
  - Raleigh, North Carolina, United States, 27609
    - Investigational Site Number 840481
  - Wilmington, North Carolina, United States, 28401
    - Investigational Site Number 840381
  - Winston Salem, North Carolina, United States, 27157-1071
    - Investigational Site Number 840532
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Investigational Site Number 840028
  - Cincinnati, Ohio, United States, 45220
    - Investigational Site Number 840198
  - Columbus, Ohio, United States, 43201
    - Investigational Site Number 840543
  - Dayton, Ohio, United States, 45439
    - Investigational Site Number 840456
  - Marion, Ohio, United States, 43302
    - Investigational Site Number 840368
- Oregon
  - Bend, Oregon, United States, 97701
    - Investigational Site Number 840427
  - Portland, Oregon, United States, 97201-3098
    - Investigational Site Number 840422
  - Portland, Oregon, United States, 97227-1191
    - Investigational Site Number 840511
- Pennsylvania
  - Butler, Pennsylvania, United States, 16001
    - Investigational Site Number 840560
  - Clark Summit, Pennsylvania, United States, 18411
    - Investigational Site Number 840464
  - Pittsburgh, Pennsylvania, United States, 15220
    - Investigational Site Number 840401
- Rhode Island
  - Providence, Rhode Island, United States, 02908
    - Investigational Site Number 840266
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Investigational Site Number 840223
  - Columbia, South Carolina, United States, 29201
    - Investigational Site Number 840353
  - Green Ville, South Carolina, United States, 29605
    - Investigational Site Number 840529
  - Greer, South Carolina, United States, 29651
    - Investigational Site Number 840550
  - Myrtle Beach, South Carolina, United States, 29572
    - Investigational Site Number 840258
  - Taylors, South Carolina, United States, 29687-4105
    - Investigational Site Number 840309
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Investigational Site Number 840551
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - Investigational Site Number 840524
  - Chattanooga, Tennessee, United States, 37404
    - Investigational Site Number 840308
  - Germantown, Tennessee, United States, 38138
    - Investigational Site Number 840047
  - Jackson, Tennessee, United States, 38305
    - Investigational Site Number 840313
  - Memphis, Tennessee, United States, 38114
    - Investigational Site Number 840625
  - Memphis, Tennessee, United States, 38163
    - Investigational Site Number 840637
  - Nashville, Tennessee, United States, 37208
    - Investigational Site Number 840096
  - Nashville, Tennessee, United States, 37232
    - Investigational Site Number 840388
- Texas
  - Dallas, Texas, United States, 75246
    - Investigational Site Number 840473
  - Edinburg, Texas, United States, 78539
    - Investigational Site Number 840677
  - El Paso, Texas, United States, 79925
    - Investigational Site Number 840698
  - Fair Oaks Ranch, Texas, United States, 78015
    - Investigational Site Number 840439
  - Houston, Texas, United States, 77081
    - Investigational Site Number 840164
  - Longview, Texas, United States, 75605
    - Investigational Site Number 840545
  - Lubbock, Texas, United States, 79409
    - Investigational Site Number 840385
  - Lubbock, Texas, United States, 79409
    - Investigational Site Number 840530
  - Marshall, Texas, United States, 75670
    - Investigational Site Number 840174
  - Plano, Texas, United States, 75024
    - Investigational Site Number 840565
  - Richmond, Texas, United States, 77469
    - Investigational Site Number 840608
  - San Antonio, Texas, United States, 78258
    - Investigational Site Number 840573
  - Sugarland, Texas, United States, 77479
    - Investigational Site Number 840564
  - Waco, Texas, United States, 76708
    - Investigational Site Number 840241
- Utah
  - American Fork, Utah, United States, 84003
    - Investigational Site Number 840232
  - Draper, Utah, United States, 84020
    - Investigational Site Number 840471
- Virginia
  - Charlottesville, Virginia, United States, 22908-0679
    - Investigational Site Number 840503
  - Chesapeake, Virginia, United States, 23320
    - Investigational Site Number 840180
  - Chesapeake, Virginia, United States, 23321
    - Investigational Site Number 840465
  - Chesapeake, Virginia, United States, 23323
    - Investigational Site Number 840128
  - Norfolk, Virginia, United States, 23502
    - Investigational Site Number 840045
  - Norfolk, Virginia, United States, 23510
    - Investigational Site Number 840213
  - Richmond, Virginia, United States, 23219
    - Investigational Site Number 840001
  - Roanoke, Virginia, United States, 24014
    - Investigational Site Number 840286
- Washington
  - Olympia, Washington, United States, 98506
    - Investigational Site Number 840170
  - Spokane, Washington, United States, 99207
    - Investigational Site Number 840094
  - Spokane, Washington, United States, 99207
    - Investigational Site Number 840343
  - Spokane, Washington, United States, 99220
    - Investigational Site Number 840268
  - Tacoma, Washington, United States, 98405
    - Investigational Site Number 840061
- Wisconsin
  - Fairmount, Wisconsin, United States, 26554
    - Investigational Site Number 840613
  - Lacrosse, Wisconsin, United States, 54601
    - Investigational Site Number 840121
  - Milwaukee, Wisconsin, United States, 53211
    - Investigational Site Number 840493

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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Men and women who experienced a spontaneous ACS event (i.e., ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation MI (NSTEMI) or unstable angina) with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or Creatinine Kinase (CK)-MB) and the clinical presentation consistent with an ACS which lead to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
Participants with a history of type 2 diabetes (for participants newly diagnosed, diagnosis was based on the World Health Organization (WHO) criteria: i.e., either a fasting venous plasma glucose concentration ≥ 7.0 mmol/L [126 mg/dL] or 2-hour post glucose load venous plasma glucose ≥ 11.1 mmol/L [200 mg/dL], confirmed on 2 occasions) prior to the screening visit.

Exclusion criteria:

Type 1 diabetes mellitus or history of ketoacidosis within 6 months prior to screening.
Glycosylated hemoglobin (HbA1c) <5.5 % or >11% measured at screening visit.
Required to use incretin-based agents (e.g., Glucagon-like peptide -1 (GLP-1) agonists or Dipeptidyl Peptidase-4 (DPP-4) inhibitors) other than the study drug during the double-blind treatment period.
Participants who had undergone coronary artery bypass graft (CABG) surgery following the qualifying ACS event.
Participants who had undergone percutaneous coronary intervention (PCI) within 15 days prior to screening.
Participants with planned revascularization procedure (PCI or CABG) or coronary angiogram within 90 days after screening visit.
History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease, personal or family history of medullary thyroid cancer (MTC), or genetic conditions that predisposes to MTC (e.g., multiple endocrine neoplasia syndromes).
Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Placebo matched to lixisenatide once daily (QD) up to end of treatment.	Drug: Placebo Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Experimental: Lixisenatide Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.	Drug: Lixisenatide (AVE0010) Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg. Other Names: Lyxumia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina Time Frame: From randomization up to the end of study (median follow-up of 25 months)	Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.	From randomization up to the end of study (median follow-up of 25 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure Time Frame: From randomization up to the end of study (median follow-up of 25 months)	All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.	From randomization up to the end of study (median follow-up of 25 months)
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure Time Frame: From randomization up to the end of study (median follow-up of 25 months)	All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.	From randomization up to the end of study (median follow-up of 25 months)
Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108 Time Frame: Baseline to Week 108 (LOCF)	Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.	Baseline to Week 108 (LOCF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

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

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

June 1, 2010

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 17, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC11319
2009-012852-26 (EudraCT Number)
U1111-1116-5558 (Other Identifier: UTN)

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Placebo

Search Similar Trials

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Drug Interventions

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CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

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Sponsor/Collaborators

Locations