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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01147250
First received: June 17, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

Primary Objective:

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

Secondary Objectives:

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

  • composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure
  • composite endpoint of cardiovascular 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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: lixisenatide (AVE0010)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to the first occurrence of the primary cardiovascular (CV) event: CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, positively adjudicated by the Cardiovascular Events Adjudication Committee (CAC) [ Time Frame: week 0 to week 203 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to the first occurrence of cardiovascular (CV) death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure positively adjudicated by the CAC [ Time Frame: week 0 to week 203 ] [ Designated as safety issue: No ]
  • Time to the first occurrence of cardiovascular (CV) death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, coronary revascularization procedure positively adjudicated by the CAC [ Time Frame: week 0 to week 203 ] [ Designated as safety issue: No ]
  • Percent change in the urinary albumin/creatinine ratio [ Time Frame: From baseline to 108 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 6000
Study Start Date: June 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide
Titration period (week 0 to 2): 10 µg lixisenatide (0.10 mL injection) once a day in the morning within 1 hour prior to breakfast Maintenance period (week 2 to 176): 20 µg lixisenatide (0.20 mL injection) once a day in the morning within 1 hour prior to breakfast
Drug: lixisenatide (AVE0010)

Pharmaceutical form:sterile aqueous solution

Route of administration: subcutaneous

Placebo Comparator: placebo
Run-in period (week -1 to 0): 10 µg volume-matched placebo ( 0.10 mL injection) once a day in the morning within 1 hour prior to breakfast Titration period (week 0 to 2): 10 µg volume-matched placebo (0.10 mL injection) once a day in the morning within 1 hour prior to breakfast Maintenance period (week 2 to 176): 20 µg volume-matched placebo (0.20 mL injection) once a day in the morning within 1 hour prior to breakfast
Drug: placebo

Pharmaceutical form:sterile aqueous solution

Route of administration: subcutaneous


Detailed Description:

The estimated maximum study duration for the first randomized patient will be approximately 204 weeks (± 14 days), with a median follow-up over all patients 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 patients will be followed from randomization until the end of study, which should occur when the last randomized patient has been followed for approximately 10 months. The actual end date of the study will be "event driven"and the study will end when there are approximately 844 positively-adjudicated primary cardiovascular outcome events.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Men and women who experienced a spontaneous acute coronary syndrome (ACS) event [i.e., ST-segment elevation myocardial infarction (STEMI)] or non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (USA)] with a documented elevation above the normal reference range of a cardiac biomarker (Troponin or CK-MB) and the clinical presentation consistent with an acute coronary syndrome which leads to admission to an acute care facility, within 180 days following the ACS event and prior to screening.
  • Patients with a history of type 2 diabetes (for patients newly diagnosed, diagnosis will be 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.
  • HbA1c <5.5 % or >11% measured at screening visit.
  • Required to use incretin-based agents (eg, GLP-1 agonists or DPP-4 inhibitors) other than the study drug during the doubleblind treatment period.
  • Patients who have undergone CABG surgery following the qualifying ACS event.
  • Patients who have undergone PCI within 15 days prior to screening.
  • Patients 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 (eg, 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 patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147250

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01147250     History of Changes
Other Study ID Numbers: EFC11319, 2009-012852-26, U1111-1116-5558
Study First Received: June 17, 2010
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014