Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
ELIXA
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
3 other identifiers
interventional
6,068
44 countries
791
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2010
Longer than P75 for phase_3
791 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
October 14, 2016
CompletedDecember 20, 2016
October 1, 2016
4.7 years
June 17, 2010
August 22, 2016
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
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 Outcomes (3)
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
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
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
Baseline to Week 108 (LOCF)
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo matched to lixisenatide once daily (QD) up to end of treatment.
Lixisenatide
EXPERIMENTALLixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.
Interventions
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.
Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (829)
Investigational Site Number 840415
Birmingham, Alabama, 35203, United States
Investigational Site Number 840307
Foley, Alabama, 36535, United States
Investigational Site Number 840692
Mobile, Alabama, 36604, United States
Investigational Site Number 840037
Mobile, Alabama, 36608, United States
Investigational Site Number 840210
Mobile, Alabama, 36609, United States
Investigational Site Number 840326
Muscle Shoals, Alabama, 35661, United States
Investigational Site Number 840393
Toney, Alabama, 35773, United States
Investigational Site Number 840656
Mesa, Arizona, 85206, United States
Investigational Site Number 840506
Phoenix, Arizona, 85012, United States
Investigational Site Number 840520
Phoenix, Arizona, 85020, United States
Investigational Site Number 840322
Phoenix, Arizona, 85032, United States
Investigational Site Number 840250
Tempe, Arizona, 85284, United States
Investigational Site Number 840042
Tucson, Arizona, 85723, United States
Investigational Site Number 840303
Hot Springs, Arkansas, 71913, United States
Investigational Site Number 840184
Jonesboro, Arkansas, 72401, United States
Investigational Site Number 840361
Little Rock, Arkansas, 72204, United States
Investigational Site Number 840023
Little Rock, Arkansas, 72205, United States
Investigational Site Number 840706
Anaheim, California, 92801, United States
Investigational Site Number 840497
Anaheim, California, 92804, United States
Investigational Site Number 840667
Downey, California, 90242, United States
Investigational Site Number 840150
Fresno, California, 93722, United States
Investigational Site Number 840624
Hawthorne, California, 90250, United States
Investigational Site Number 840623
Inglewood, California, 90301, United States
Investigational Site Number 840636
Inglewood, California, 90301, United States
Investigational Site Number 840455
La Mesa, California, 91942, United States
Investigational Site Number 840240
Loma Linda, California, 92354, United States
Investigational Site Number 840262
Long Beach, California, 90806, United States
Investigational Site Number 840606
Long Beach, California, 90813, United States
Investigational Site Number 840694
Los Angeles, California, 90024, United States
Investigational Site Number 840431
Los Angeles, California, 90033, United States
Investigational Site Number 840135
Los Angeles, California, 90073, United States
Investigational Site Number 840314
Merced, California, 95348, United States
Investigational Site Number 840290
Mission Viejo, California, 92691, United States
Investigational Site Number 840592
National City, California, 91950, United States
Investigational Site Number 840275
Northridge, California, 91328, United States
Investigational Site Number 840654
Oakland, California, 94609, United States
Investigational Site Number 840351
Orange, California, 92868, United States
Investigational Site Number 840689
Orange, California, 92868, United States
Investigational Site Number 840582
Pomona, California, 91767, United States
Investigational Site Number 840346
Port Hueneme, California, 93041, United States
Investigational Site Number 840466
Roseville, California, 95661, United States
Investigational Site Number 840575
San Marino, California, 91108, United States
Investigational Site Number 840131
Santa Ana, California, 82705, United States
Investigational Site Number 840335
Santa Ana, California, 92704, United States
Investigational Site Number 840576
Simi Valley, California, 93065, United States
Investigational Site Number 840414
Sylmar, California, 91342, United States
Investigational Site Number 840395
Ventura, California, 93003, United States
Investigational Site Number 840206
Vista, California, 92081-7832, United States
Investigational Site Number 840480
Westlake Village, California, 91361, United States
Investigational Site Number 840350
Whittier, California, 90602, United States
Investigational Site Number 840093
Colorado Springs, Colorado, 80910, United States
Investigational Site Number 840631
Washington D.C., District of Columbia, 20060, United States
Investigational Site Number 840044
Washington D.C., District of Columbia, 20422, United States
Investigational Site Number 840281
Clearwater, Florida, 33755, United States
Investigational Site Number 840477
Homosassa, Florida, 34448, United States
Investigational Site Number 840261
Miami, Florida, 33135, United States
Investigational Site Number 840459
Miami, Florida, 33155, United States
Investigational Site Number 840432
Oviedo, Florida, 32765, United States
Investigational Site Number 840318
Panama City, Florida, 32401, United States
Investigational Site Number 840056
St. Petersburg, Florida, 33707, United States
Investigational Site Number 840295
Wellington, Florida, 33449, United States
Investigational Site Number 840066
Atlanta, Georgia, 30322, United States
Investigational Site Number 840446
Atlanta, Georgia, 30322, United States
Investigational Site Number 840487
Atlanta, Georgia, 30322, United States
Investigational Site Number 840578
Blue Ridge, Georgia, 30513, United States
Investigational Site Number 840534
Columbus, Georgia, 31904-5245, United States
Investigational Site Number 840447
Duluth, Georgia, 30096, United States
Investigational Site Number 840499
Duluth, Georgia, 30096, United States
Investigational Site Number 840536
Idaho Falls, Idaho, 83404, United States
Investigational Site Number 840413
Pocatello, Idaho, 83201, United States
Investigational Site Number 840519
Arlington Heights, Illinois, 60005, United States
Investigational Site Number 840589
Belleville, Illinois, 62220, United States
Investigational Site Number 840107
Chicago, Illinois, 60415, United States
Investigational Site Number 840633
Chicago, Illinois, 60611, United States
Investigational Site Number 840663
Chicago, Illinois, 60612, United States
Investigational Site Number 840212
Hines, Illinois, 60141, United States
Investigational Site Number 840345
Joliet, Illinois, 60435, United States
Investigational Site Number 840681
Peoria, Illinois, 61602, United States
Investigational Site Number 840360
Elwood, Indiana, 46036, United States
Investigational Site Number 840676
Gary, Indiana, 46409, United States
Investigational Site Number 840657
Hammond, Indiana, 46320, United States
Investigational Site Number 840621
Huntington, Indiana, 46750, United States
Investigational Site Number 840702
Indianapolis, Indiana, 46202, United States
Investigational Site Number 840009
Topeka, Kansas, 66606, United States
Investigational Site Number 840533
Covington, Kentucky, 41011, United States
Investigational Site Number 840251
Madisonville, Kentucky, 42431, United States
Investigational Site Number 840168
Owensboro, Kentucky, 42303, United States
Investigational Site Number 840449
Pikeville, Kentucky, 41501, United States
Investigational Site Number 840299
Baton Rouge, Louisiana, 70808, United States
Investigational Site Number 840671
Hammond, Louisiana, 70403, United States
Investigational Site Number 840470
Metairie, Louisiana, 70006, United States
Investigational Site Number 840178
Shreveport, Louisiana, 71130, United States
Investigational Site Number 840043
Annapolis, Maryland, 21401, United States
Investigational Site Number 840639
Catonsville, Maryland, 21228, United States
Investigational Site Number 840430
Rockville, Maryland, 20852, United States
Investigational Site Number 840640
Takoma Park, Maryland, 20912, United States
Investigational Site Number 840293
Towson, Maryland, 21204, United States
Investigational Site Number 840019
Alpena, Michigan, 49707, United States
Investigational Site Number 840352
Buckley, Michigan, 49620, United States
Investigational Site Number 840555
Chesterfield, Michigan, 48047, United States
Investigational Site Number 840411
Dearborn, Michigan, 48124, United States
Investigational Site Number 840205
Detroit, Michigan, 48235, United States
Investigational Site Number 840581
Flint, Michigan, 48503, United States
Investigational Site Number 840404
Kalamazoo, Michigan, 49048, United States
Investigational Site Number 840312
Southfield, Michigan, 48075, United States
Investigational Site Number 840484
Sterling Heights, Michigan, 48310, United States
Investigational Site Number 840219
Duluth, Minnesota, 55805, United States
Investigational Site Number 840199
Eagan, Minnesota, 55122, United States
Investigational Site Number 840196
Biloxi, Mississippi, 39531, United States
Investigational Site Number 840445
Kansas City, Missouri, 64111, United States
Investigational Site Number 840008
Kansas City, Missouri, 64128, United States
Investigational Site Number 840091
St Louis, Missouri, 63122, United States
Investigational Site Number 840046
St Louis, Missouri, 63128, United States
Investigational Site Number 840678
St Louis, Missouri, 63131, United States
Investigational Site Number 840400
St Louis, Missouri, 63141, United States
Investigational Site Number 840337
Kalispell, Montana, 59901, United States
Investigational Site Number 840509
Lincoln, Nebraska, 68521, United States
Investigational Site Number 840007
Omaha, Nebraska, 68131, United States
Investigational Site Number 840382
Las Vegas, Nevada, 89102, United States
Investigational Site Number 840680
Las Vegas, Nevada, 89102, United States
Investigational Site Number 840217
Las Vegas, Nevada, 89148, United States
Investigational Site Number 840072
Linden, New Jersey, United States
Investigational Site Number 840628
Ridgewood, New Jersey, 07450, United States
Investigational Site Number 840162
Somerset, New Jersey, 08873, United States
Investigational Site Number 840285
Albany, New York, 12206, United States
Investigational Site Number 840585
Jamaica, New York, 11432, United States
Investigational Site Number 840348
Mineola, New York, 11501, United States
Investigational Site Number 840119
Northport, New York, 11768, United States
Investigational Site Number 840696
Rosedale, New York, 14221, United States
Investigational Site Number 840310
Asheville, North Carolina, 28805, United States
Investigational Site Number 840454
Calabash, North Carolina, 28467, United States
Investigational Site Number 840672
Charlotte, North Carolina, 28203, United States
Investigational Site Number 840152
Charlotte, North Carolina, 28205, United States
Investigational Site Number 840344
Elizabeth City, North Carolina, 27909, United States
Investigational Site Number 840328
Greensboro, North Carolina, 27401, United States
Investigational Site Number 840513
Greensboro, North Carolina, 27405, United States
Investigational Site Number 840504
Greenville, North Carolina, 27858, United States
Investigational Site Number 840642
Monroe, North Carolina, 28110, United States
Investigational Site Number 840481
Raleigh, North Carolina, 27609, United States
Investigational Site Number 840381
Wilmington, North Carolina, 28401, United States
Investigational Site Number 840532
Winston-Salem, North Carolina, 27157-1071, United States
Investigational Site Number 840028
Cincinnati, Ohio, 45219, United States
Investigational Site Number 840198
Cincinnati, Ohio, 45220, United States
Investigational Site Number 840543
Columbus, Ohio, 43201, United States
Investigational Site Number 840456
Dayton, Ohio, 45439, United States
Investigational Site Number 840368
Marion, Ohio, 43302, United States
Investigational Site Number 840427
Bend, Oregon, 97701, United States
Investigational Site Number 840422
Portland, Oregon, 97201-3098, United States
Investigational Site Number 840511
Portland, Oregon, 97227-1191, United States
Investigational Site Number 840560
Butler, Pennsylvania, 16001, United States
Investigational Site Number 840464
Clark Summit, Pennsylvania, 18411, United States
Investigational Site Number 840401
Pittsburgh, Pennsylvania, 15220, United States
Investigational Site Number 840266
Providence, Rhode Island, 02908, United States
Investigational Site Number 840223
Anderson, South Carolina, 29621, United States
Investigational Site Number 840353
Columbia, South Carolina, 29201, United States
Investigational Site Number 840529
Greenville, South Carolina, 29605, United States
Investigational Site Number 840550
Greer, South Carolina, 29651, United States
Investigational Site Number 840258
Myrtle Beach, South Carolina, 29572, United States
Investigational Site Number 840309
Taylors, South Carolina, 29687-4105, United States
Investigational Site Number 840551
Rapid City, South Dakota, 57701, United States
Investigational Site Number 840524
Bartlett, Tennessee, 38133, United States
Investigational Site Number 840308
Chattanooga, Tennessee, 37404, United States
Investigational Site Number 840047
Germantown, Tennessee, 38138, United States
Investigational Site Number 840313
Jackson, Tennessee, 38305, United States
Investigational Site Number 840625
Memphis, Tennessee, 38114, United States
Investigational Site Number 840637
Memphis, Tennessee, 38163, United States
Investigational Site Number 840096
Nashville, Tennessee, 37208, United States
Investigational Site Number 840388
Nashville, Tennessee, 37232, United States
Investigational Site Number 840473
Dallas, Texas, 75246, United States
Investigational Site Number 840677
Edinburg, Texas, 78539, United States
Investigational Site Number 840698
El Paso, Texas, 79925, United States
Investigational Site Number 840439
Fair Oaks Ranch, Texas, 78015, United States
Investigational Site Number 840164
Houston, Texas, 77081, United States
Investigational Site Number 840545
Longview, Texas, 75605, United States
Investigational Site Number 840385
Lubbock, Texas, 79409, United States
Investigational Site Number 840530
Lubbock, Texas, 79409, United States
Investigational Site Number 840174
Marshall, Texas, 75670, United States
Investigational Site Number 840565
Plano, Texas, 75024, United States
Investigational Site Number 840608
Richmond, Texas, 77469, United States
Investigational Site Number 840573
San Antonio, Texas, 78258, United States
Investigational Site Number 840564
Sugarland, Texas, 77479, United States
Investigational Site Number 840241
Waco, Texas, 76708, United States
Investigational Site Number 840232
American Fork, Utah, 84003, United States
Investigational Site Number 840471
Draper, Utah, 84020, United States
Investigational Site Number 840503
Charlottesville, Virginia, 22908-0679, United States
Investigational Site Number 840180
Chesapeake, Virginia, 23320, United States
Investigational Site Number 840465
Chesapeake, Virginia, 23321, United States
Investigational Site Number 840128
Chesapeake, Virginia, 23323, United States
Investigational Site Number 840045
Norfolk, Virginia, 23502, United States
Investigational Site Number 840213
Norfolk, Virginia, 23510, United States
Investigational Site Number 840001
Richmond, Virginia, 23219, United States
Investigational Site Number 840286
Roanoke, Virginia, 24014, United States
Investigational Site Number 840170
Olympia, Washington, 98506, United States
Investigational Site Number 840094
Spokane, Washington, 99207, United States
Investigational Site Number 840343
Spokane, Washington, 99207, United States
Investigational Site Number 840268
Spokane, Washington, 99220, United States
Investigational Site Number 840061
Tacoma, Washington, 98405, United States
Investigational Site Number 840613
Fairmount, Wisconsin, 26554, United States
Investigational Site Number 840121
La Crosse, Wisconsin, 54601, United States
Investigational Site Number 840493
Milwaukee, Wisconsin, 53211, United States
Investigational Site Number 032028
Adrogué, B1846DSK, Argentina
Investigational Site Number 032030
Bahía Blanca, B8000AKK, Argentina
Investigational Site Number 032043
Bahía Blanca, B8000FTD, Argentina
Investigational Site Number 032054
Bahía Blanca, B8001HXM, Argentina
Investigational Site Number 032066
Caba, 1120, Argentina
Investigational Site Number 032049
Caba, 1440, Argentina
Investigational Site Number 032056
Caba, C1181ACL, Argentina
Investigational Site Number 032003
Caba, C1425AGC, Argentina
Investigational Site Number 032017
Capital Federal, C1056ABJ, Argentina
Investigational Site Number 032009
Capital Federal, C1179AAB, Argentina
Investigational Site Number 032050
Cipolletti, 8324, Argentina
Investigational Site Number 032052
Ciudad Autonoma de Bs.As, 1428, Argentina
Investigational Site Number 032020
Coronel Suárez, B7540GHD, Argentina
Investigational Site Number 032004
Corrientes, 3400, Argentina
Investigational Site Number 032018
Corrientes, W3410AVV, Argentina
Investigational Site Number 032015
Córdoba, 5000, Argentina
Investigational Site Number 032011
Córdoba, X50009BSN, Argentina
Investigational Site Number 032022
Córdoba, X5000AAW, Argentina
Investigational Site Number 032037
Córdoba, X5000AAX, Argentina
Investigational Site Number 032005
Godoy Cruz, M5501ARP, Argentina
Investigational Site Number 032042
Haedo, 1706, Argentina
Investigational Site Number 032019
Junín, B6000BHA, Argentina
Investigational Site Number 032063
La Plata, 1900, Argentina
Investigational Site Number 032040
Lanús, 1824, Argentina
Investigational Site Number 032036
Mar del Plata, B7600, Argentina
Investigational Site Number 032039
Mar del Plata, C7600CBM, Argentina
Investigational Site Number 032058
Mendoza, 5500, Argentina
Investigational Site Number 032038
Morón, 1708, Argentina
Investigational Site Number 032002
Paraná, E3100BBJ, Argentina
Investigational Site Number 032023
Qilmes, b1878dkf, Argentina
Investigational Site Number 032047
Rafaela, S2300MMA, Argentina
Investigational Site Number 032024
Ramos Mejía, 1704, Argentina
Investigational Site Number 032006
Resistencia, H3500CDM, Argentina
Investigational Site Number 032012
Rosario, 2000CVD, Argentina
Investigational Site Number 032027
Rosario, S2000DSR, Argentina
Investigational Site Number 032055
Salta, 4400, Argentina
Investigational Site Number 032065
Salta, 4400, Argentina
Investigational Site Number 032051
San Miguel de Tucumán, 4000, Argentina
Investigational Site Number 032008
San Miguel de Tucumán, T4000ICL, Argentina
Investigational Site Number 032033
San Nicolás, B2900DMH, Argentina
Investigational Site Number 032045
Santa Fe, S3000AZG, Argentina
Investigational Site Number 032035
Santa Fe, S3000FWO, Argentina
Investigational Site Number 032062
Santa Rosa, L6300DSD, Argentina
Investigational Site Number 032034
Venado Tuerto, S2600KUE, Argentina
Investigational Site Number 032046
Villa María, X5900JKA, Argentina
Investigational Site Number 032029
Zárate, B2800DGH, Argentina
Investigational Site Number 036015
Epping, 3076, Australia
Investigational Site Number 036001
Fremantle, 6160, Australia
Investigational Site Number 036009
Geelong, 3220, Australia
Investigational Site Number 036011
Perth, 6000, Australia
Investigational Site Number 036005
St Leonards, 2065, Australia
Investigational Site Number 036016
Townsville, 4810, Australia
Investigational Site Number 040002
Graz, 8036, Austria
Investigational Site Number 040001
Vienna, 1160, Austria
Investigational Site Number 112002
Minsk, 220036, Belarus
Investigational Site Number 112003
Minsk, 220096, Belarus
Investigational Site Number 112001
Minsk, 220116, Belarus
Investigational Site Number 056001
Brussels, 1200, Belgium
Investigational Site Number 056003
Leuven, 3000, Belgium
Investigational Site Number 076024
Belém, 66087-660, Brazil
Investigational Site Number 076006
Belo Horizonte, 30150-221, Brazil
Investigational Site Number 076012
Belo Horizonte, 30150-221, Brazil
Investigational Site Number 076021
Brasília, 70310-500, Brazil
Investigational Site Number 076002
Campinas, 13015-001, Brazil
Investigational Site Number 076019
Curitiba, 80730-150, Brazil
Investigational Site Number 076003
Fortaleza, 60115-282, Brazil
Investigational Site Number 076018
Fortaleza, 60170-320, Brazil
Investigational Site Number 076004
Fortaleza, 60430-370, Brazil
Investigational Site Number 076023
Goiânia, 74823470, Brazil
Investigational Site Number 076014
Marília, 17515-240, Brazil
Investigational Site Number 076015
Passo Fundo, 99010-180, Brazil
Investigational Site Number 076008
Porto Alegre, 90020-090, Brazil
Investigational Site Number 076013
Porto Alegre, 90035-001, Brazil
Investigational Site Number 076026
Porto Alegre, 90620-001, Brazil
Investigational Site Number 076025
Recife, 52051-380, Brazil
Investigational Site Number 076020
Salvador, 40050-410, Brazil
Investigational Site Number 076016
São Paulo, 01323-001, Brazil
Investigational Site Number 076010
São Paulo, 04012-180, Brazil
Investigational Site Number 076001
São Paulo, 04024-002, Brazil
Investigational Site Number 076005
São Paulo, 05403-000, Brazil
Investigational Site Number 076007
Uberlândia, 38400-368, Brazil
Investigational Site Number 100002
Byala, 7100, Bulgaria
Investigational Site Number 100011
Gabrovo, 5300, Bulgaria
Investigational Site Number 100001
Kazanlak, 6100, Bulgaria
Investigational Site Number 100006
Lovech, 5500, Bulgaria
Investigational Site Number 100004
Pleven, 5800, Bulgaria
Investigational Site Number 100003
Plovdiv, 4002, Bulgaria
Investigational Site Number 100007
Plovdiv, 4002, Bulgaria
Investigational Site Number 100016
Sandanski, 2800, Bulgaria
Investigational Site Number 100010
Sofia, 1606, Bulgaria
Investigational Site Number 100015
Sofia, 1618, Bulgaria
Investigational Site Number 100005
Varna, 9000, Bulgaria
Investigational Site Number 124024
Calgary, T2N 4N1, Canada
Investigational Site Number 124016
Cambridge, N1R 7Z6, Canada
Investigational Site Number 124026
Edmonton, T6G 2B7, Canada
Investigational Site Number 124005
Greater Sudbury, P3C 5K7, Canada
Investigational Site Number 124001
Laval, H7T 2P5, Canada
Investigational Site Number 124021
Montreal, H1T 1C8, Canada
Investigational Site Number 124006
Montreal, H3Z 1E5, Canada
Investigational Site Number 124027
Oshawa, L1J 2J9, Canada
Investigational Site Number 124025
Québec, G1V 4G5, Canada
Investigational Site Number 124028
Red Deer, T4N 6V7, Canada
Investigational Site Number 124003
Saint-Marc-des-Carrieres, G0A 4B0, Canada
Investigational Site Number 124007
Sarnia, N7T 4R9, Canada
Investigational Site Number 124002
Thetford-Mines, G6G 2V4, Canada
Investigational Site Number 152024
Antofagasta, 1270001, Chile
Investigational Site Number 152023
Concepción, 4070038, Chile
Investigational Site Number 152041
Osorno, 5311092, Chile
Investigational Site Number 152040
Port Montt, 5480000, Chile
Investigational Site Number 152038
Punta Arenas, 6210005, Chile
Investigational Site Number 152036
San Felipe, 2172972, Chile
Investigational Site Number 152035
Santiago, 285-1950, Chile
Investigational Site Number 152020
Santiago, 7500010, Chile
Investigational Site Number 152028
Santiago, 7500503, Chile
Investigational Site Number 152031
Santiago, 7500520, Chile
Investigational Site Number 152001
Santiago, 7500710, Chile
Investigational Site Number 152034
Santiago, 7500710, Chile
Investigational Site Number 152008
Santiago, 7591047, Chile
Investigational Site Number 152013
Santiago, 7591047, Chile
Investigational Site Number 152019
Santiago, 7650018, Chile
Investigational Site Number 152018
Santiago, 7980378, Chile
Investigational Site Number 152042
Santiago, 80004005, Chile
Investigational Site Number 152015
Santiago, 8053095, Chile
Investigational Site Number 152004
Santiago, 8350595, Chile
Investigational Site Number 152029
Santiago, 838-0456, Chile
Investigational Site Number 152022
Santiago, 8380456, Chile
Investigational Site Number 152011
Santiago, 890-0085, Chile
Investigational Site Number 152025
Talca, 9999, Chile
Investigational Site Number 152014
Temuco, 4781173, Chile
Investigational Site Number 152003
Temuco, 4813299, Chile
Investigational Site Number 152037
Valdivia, 5090146, Chile
Investigational Site Number 152032
Valparaíso, 234-0207, Chile
Investigational Site Number 152010
Viña del Mar, 2570017, Chile
Investigational Site Number 152002
Viña del Mar, Chile
Investigational Site Number 156016
Beijing, 100029, China
Investigational Site Number 156034
Beijing, 100029, China
Investigational Site Number 156024
Beijing, 100034, China
Investigational Site Number 156028
Beijing, 100037, China
Investigational Site Number 156014
Beijing, 100088, China
Investigational Site Number 156005
Beijing, 100730, China
Investigational Site Number 156006
Beijing, 100730, China
Investigational Site Number 156001
Beijing, 100853, China
Investigational Site Number 156008
Dalian, 116011, China
Investigational Site Number 156020
Guangzhou, 510080, China
Investigational Site Number 156023
Jinan, 250012, China
Investigational Site Number 156015
Jinan, 250013, China
Investigational Site Number 156009
Nanjing, 210008, China
Investigational Site Number 156013
Shanghai, 200003, China
Investigational Site Number 156019
Shanghai, 200080, China
Investigational Site Number 156032
Shenyang, 110004, China
Investigational Site Number 156022
Shenyang, 110016, China
Investigational Site Number 156004
Suzhou, 215006, China
Investigational Site Number 156033
Ürümqi, 830054, China
Investigational Site Number 170025
Armenia, Colombia
Investigational Site Number 170009
Barranquilla, Colombia
Investigational Site Number 170010
Barranquilla, Colombia
Investigational Site Number 170002
Bogotá, Colombia
Investigational Site Number 170005
Bogotá, Colombia
Investigational Site Number 170012
Bogotá, Colombia
Investigational Site Number 170014
Bogotá, Colombia
Investigational Site Number 170022
Bogotá, 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 170003
Medellín, Colombia
Investigational Site Number 170020
Medellín, Colombia
Investigational Site Number 170021
Pereira, Colombia
Investigational Site Number 208003
Aarhus, 8000, Denmark
Investigational Site Number 208009
Aarhus C, 8000, Denmark
Investigational Site Number 208011
Esbjerg, 6700, Denmark
Investigational Site Number 208004
Farsø, 9640, Denmark
Investigational Site Number 208002
Hellerup, 2900, Denmark
Investigational Site Number 208010
Herlev, 2730, Denmark
Investigational Site Number 208008
Hillerød, 3400, Denmark
Investigational Site Number 208006
Hvidovre, 2650, Denmark
Investigational Site Number 208001
København NV, 2400, Denmark
Investigational Site Number 208005
København S, 2300, Denmark
Investigational Site Number 208007
København Ø, 2100, Denmark
Investigational Site Number 218001
Guayaquil, EC090112, Ecuador
Investigational Site Number 218005
Guayaquil, EC09112, Ecuador
Investigational Site Number 218002
Quito, EC090112, Ecuador
Investigational Site Number 818002
Alexandria, Egypt
Investigational Site Number 818001
Cairo, Egypt
Investigational Site Number 233004
Tallinn, 10138, Estonia
Investigational Site Number 233002
Tallinn, 13415, Estonia
Investigational Site Number 233001
Tallinn, 13419, Estonia
Investigational Site Number 233003
Tallinn, 13419, Estonia
Investigational Site Number 233005
Tartu, 50406, Estonia
Investigational Site Number 233006
Viljandimaa, 71024, Estonia
Investigational Site Number 246005
Jyväskylä, 40620, Finland
Investigational Site Number 246003
Rauma, 26100, Finland
Investigational Site Number 246010
Tampere, 33520, Finland
Investigational Site Number 246009
Turku, FIN-20520, Finland
Investigational Site Number 246007
Valkeakoski, 37600, Finland
Investigational Site Number 246012
Vantaa, 01600, Finland
Investigational Site Number 250008
Brest, 29610, France
Investigational Site Number 250002
Corbeil-Essonnes, 91109, France
Investigational Site Number 250005
Nantes, 44093, France
Investigational Site Number 250014
Nîmes, 30029, France
Investigational Site Number 250007
Paris, 75908, France
Investigational Site Number 250011
Pessac, 33600, France
Investigational Site Number 250012
Poitiers, 86021, France
Investigational Site Number 250006
Rennes, 35700, France
Investigational Site Number 250001
Toulouse, 31403, France
Investigational Site Number 268003
Batumi, Georgia
Investigational Site Number 268004
Kutaisi, Georgia
Investigational Site Number 268001
Tbilisi, Georgia
Investigational Site Number 268002
Tbilisi, Georgia
Investigational Site Number 276003
Berlin, 13347, Germany
Investigational Site Number 276022
Bochum, 44787, Germany
Investigational Site Number 276005
Chemnitz, 09111, Germany
Investigational Site Number 276021
Dresden, 01067, Germany
Investigational Site Number 276024
Dresden, 01099, Germany
Investigational Site Number 276007
Elsterwerda, 04910, Germany
Investigational Site Number 276018
Frankfurt A.M., 60596, Germany
Investigational Site Number 276011
Frankfurt am Main, 60389, Germany
Investigational Site Number 276017
Görlitz, 02826, Germany
Investigational Site Number 276025
Haßloch, 67454, Germany
Investigational Site Number 276009
Heidelberg, 69120, Germany
Investigational Site Number 276019
Leipzig, 04103, Germany
Investigational Site Number 276020
Magdeburg, 39104, Germany
Investigational Site Number 276028
Mühldorf, 84453, Germany
Investigational Site Number 276014
Pirna, 01796, Germany
Investigational Site Number 276016
Pohlheim, 35415, Germany
Investigational Site Number 276026
Rotenburg an der Fulda, 36199, Germany
Investigational Site Number 320004
Guatemala City, 01010, Guatemala
Investigational Site Number 320006
Guatemala City, 01010, Guatemala
Investigational Site Number 320012
Guatemala City, 01010, Guatemala
Investigational Site Number 320014
Guatemala City, 01010, Guatemala
Investigational Site Number 320001
Guatemala City, 01014, Guatemala
Investigational Site Number 320002
Guatemala City, 01014, Guatemala
Investigational Site Number 320007
Guatemala City, 01014, Guatemala
Investigational Site Number 320008
Guatemala City, 01014, Guatemala
Investigational Site Number 320011
Guatemala City, 01015, Guatemala
Investigational Site Number 320015
Quetzaltenango, 09001, Guatemala
Investigational Site Number 356019
Ahmedabad, 380052, India
Investigational Site Number 356002
Bangalore, 560043, India
Investigational Site Number 356010
Bangalore, 560092, India
Investigational Site Number 356026
Bangalore, 562114, India
Investigational Site Number 356024
Belagavi, 590001, India
Investigational Site Number 356012
Chandigarh, 160062, India
Investigational Site Number 356022
Gūrgaon, 122002, India
Investigational Site Number 356029
Hubli, 580021, India
Investigational Site Number 356020
Hyderabad, 500063, India
Investigational Site Number 356031
Jaipur, 302001, India
Investigational Site Number 356016
Kochi, 682026, India
Investigational Site Number 356004
Kolkata, India
Investigational Site Number 356015
Lucknow, 226003, India
Investigational Site Number 356014
Lucknow, India
Investigational Site Number 356009
Ludhiana, 141001, India
Investigational Site Number 356025
Madurai, India
Investigational Site Number 356032
Mangalore, 575002, India
Investigational Site Number 356018
Manipal, 576104, India
Investigational Site Number 356023
Mysore, 570020, India
Investigational Site Number 356027
Nagpur, 440010, India
Investigational Site Number 356006
Nagpur, India
Investigational Site Number 356030
Nashik, 422002, India
Investigational Site Number 356034
Nashik, 422005, India
Investigational Site Number 356013
New Delhi, 110017, India
Investigational Site Number 356017
New Delhi, 122001, India
Investigational Site Number 356021
Pune, 411001, India
Investigational Site Number 356028
Pune, 411019, India
Investigational Site Number 376010
Afula, 18101, Israel
Investigational Site Number 376006
Giv‘atayim, 53583, Israel
Investigational Site Number 376002
Haifa, 31096, Israel
Investigational Site Number 376008
Haifa, 35251, Israel
Investigational Site Number 376001
Holon, 58100, Israel
Investigational Site Number 376012
Jerusalem, 91120, Israel
Investigational Site Number 376011
Nahariya, 22100, Israel
Investigational Site Number 376005
Safed, 13100, Israel
Investigational Site Number 376004
Tel Aviv, 64239, Israel
Investigational Site Number 376003
Tel Litwinsky, 52621, Israel
Investigational Site Number 376009
Tzrifin, 70300, Israel
Investigational Site Number 380024
Carpi, 41012, Italy
Investigational Site Number 380004
Chieri, 10023, Italy
Investigational Site Number 380002
Chieti, 66013, Italy
Investigational Site Number 380006
Fermo, 63023, Italy
Investigational Site Number 380010
Florence, 50141, Italy
Investigational Site Number 380009
Genova, 16011, Italy
Investigational Site Number 380016
Messina, 98124, Italy
Investigational Site Number 380023
Milan, 20122, Italy
Investigational Site Number 380011
Milan, 20132, Italy
Investigational Site Number 380012
Milan, 20142, Italy
Investigational Site Number 380014
Napoli, 80131, Italy
Investigational Site Number 380019
Novara, 28100, Italy
Investigational Site Number 380005
Palermo, 90127, Italy
Investigational Site Number 380001
Pisa, 56124, Italy
Investigational Site Number 380013
Roma, 00128, Italy
Investigational Site Number 380020
Rozzano, 20089, Italy
Investigational Site Number 392011
Chūōku, 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, 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, Japan
Investigational Site Number 392007
Matsuyama, Japan
Investigational Site Number 392008
Matsuyama, Japan
Investigational Site Number 392009
Nagasaki, Japan
Investigational Site Number 392002
Noda, Japan
Investigational Site Number 392020
Osaka, Japan
Investigational Site Number 392021
Osaka, Japan
Investigational Site Number 392001
Sapporo, Japan
Investigational Site Number 392010
Sapporo, 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
Investigational Site Number 428005
Cēsis, LV-4101, Latvia
Investigational Site Number 428001
Daugavpils, LV-5417, Latvia
Investigational Site Number 428002
Liepāja, LV-3414, Latvia
Investigational Site Number 428003
Riga, LV-1002, Latvia
Investigational Site Number 428007
Riga, LV-1011, Latvia
Investigational Site Number 428004
Riga, LV-1038, Latvia
Investigational Site Number 428006
Sigulda, LV-2150, Latvia
Investigational Site Number 440003
Kaunas, LT-49456, Lithuania
Investigational Site Number 440002
Kaunas, LT-50009, Lithuania
Investigational Site Number 440004
Klaipėda, LT-91131, Lithuania
Investigational Site Number 440006
Klaipėda, LT-92304, Lithuania
Investigational Site Number 440005
Panevezys, LT-37355, Lithuania
Investigational Site Number 440001
Vilnius, LT-08661, Lithuania
Investigational Site Number 484011
Acapulco, 39670, Mexico
Investigational Site Number 484008
Aguascalientes, 20230, Mexico
Investigational Site Number 484033
Aguascalientes, 20230, Mexico
Investigational Site Number 484016
Chihuahua City, 31000, Mexico
Investigational Site Number 484023
Ciudad Madero, 89440, Mexico
Investigational Site Number 484007
Durango, 34000, Mexico
Investigational Site Number 484001
Durango, 34080, Mexico
Investigational Site Number 484041
Durango, 34080, Mexico
Investigational Site Number 484032
Guadalajara, 44150, Mexico
Investigational Site Number 484034
Guadalajara, 44160, Mexico
Investigational Site Number 484014
Guadalajara, 44210, Mexico
Investigational Site Number 484028
Guadalajara, 44210, Mexico
Investigational Site Number 484021
Guadalajara, 44670, Mexico
Investigational Site Number 484006
Guadalajara, 44680, Mexico
Investigational Site Number 484018
Guadalajara, 45200, Mexico
Investigational Site Number 484024
León, 37150, Mexico
Investigational Site Number 484026
Mexico City, 06470, Mexico
Investigational Site Number 484022
Mexico City, 07300, Mexico
Investigational Site Number 484013
Mexico City, 14000, Mexico
Investigational Site Number 484003
Monterrey, 64020, Mexico
Investigational Site Number 484025
Monterrey, 64060, Mexico
Investigational Site Number 484002
Monterrey, 64460, Mexico
Investigational Site Number 484005
Monterrey, 64460, Mexico
Investigational Site Number 484004
Monterrey, 64620, Mexico
Investigational Site Number 484035
Morelia, 58260, Mexico
Investigational Site Number 484020
San Luis Potosí City, 78200, Mexico
Investigational Site Number 484017
Tlalnepantla, 54055, Mexico
Investigational Site Number 484031
Xalapa, 91020, Mexico
Investigational Site Number 528005
Alkmaar, 1815 JD, Netherlands
Investigational Site Number 528008
Deventer, 7416 SE, Netherlands
Investigational Site Number 528004
Hoorn, 1625 HV, Netherlands
Investigational Site Number 528001
Rotterdam, 3045 PM, Netherlands
Investigational Site Number 528007
The Hague, 2597 AX, Netherlands
Investigational Site Number 528003
Tilburg, 5022 GC, Netherlands
Investigational Site Number 528006
Venlo, 5912 BL, Netherlands
Investigational Site Number 578003
Bodø, 8092, Norway
Investigational Site Number 578002
Haugesund, 5528, Norway
Investigational Site Number 578001
Stavanger, 4095, Norway
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
Penonomé, Panama
Investigational Site Number 604007
Arequipa, 5154, Peru
Investigational Site Number 604014
Callao, CALLAO 2, Peru
Investigational Site Number 604011
Lima, 051, Peru
Investigational Site Number 604019
Lima, 051, Peru
Investigational Site Number 604013
Lima, 11, Peru
Investigational Site Number 604010
Lima, 12, Peru
Investigational Site Number 604002
Lima, 27, Peru
Investigational Site Number 604006
Lima, 27, Peru
Investigational Site Number 604015
Lima, 511, Peru
Investigational Site Number 604016
Lima, 511, Peru
Investigational Site Number 604017
Lima, LIMA 01, Peru
Investigational Site Number 604018
Lima, LIMA 11, Peru
Investigational Site Number 604005
Lima, LIMA 14, Peru
Investigational Site Number 604009
Lima, LIMA 27, Peru
Investigational Site Number 604001
Lima, LIMA 31, Peru
Investigational Site Number 608006
Cavite, Philippines
Investigational Site Number 608009
Iligan City, Lanao Del Norte, 9200, Philippines
Investigational Site Number 608003
Makati City, Philippines
Investigational Site Number 608001
Manila, 1008, Philippines
Investigational Site Number 608007
Manila, Philippines
Investigational Site Number 608005
Marikina City, 1800, Philippines
Investigational Site Number 608002
Pasay, 1300, Philippines
Investigational Site Number 608008
Quezon City, 1109, Philippines
Investigational Site Number 616005
?ód?, 91-087, Poland
Investigational Site Number 616008
Bialystok, 15-276, Poland
Investigational Site Number 616019
Bydgoszcz, 85-046, Poland
Investigational Site Number 616012
Czeladź, 41-250, Poland
Investigational Site Number 616007
Częstochowa, 42-217, Poland
Investigational Site Number 616014
Gdynia, 81-394, Poland
Investigational Site Number 616013
Gliwice, 44-100, Poland
Investigational Site Number 616028
Grodzisk Mazowiecki, 05-825, Poland
Investigational Site Number 616022
Katowice, 40-767, Poland
Investigational Site Number 616001
Krakow, 30-082, Poland
Investigational Site Number 616024
Krakow, 31-024, Poland
Investigational Site Number 616023
Poland, 42-500, Poland
Investigational Site Number 616021
Puławy, 24-100, Poland
Investigational Site Number 616006
Ruda Śląska, 41-706, Poland
Investigational Site Number 616025
Szczecin, 70-506, Poland
Investigational Site Number 616032
Warsaw, 00-685, Poland
Investigational Site Number 616020
Wroclaw, 50-088, Poland
Investigational Site Number 616011
Wroclaw, 50-981, Poland
Investigational Site Number 616031
Zgierz, 95-100, Poland
Investigational Site Number 616029
Łęczyca, 99-100, Poland
Investigational Site Number 620005
Amadora, 2720-276, Portugal
Investigational Site Number 620003
Coimbra, 3000-075, Portugal
Investigational Site Number 620001
Lisbon, 1349-019, Portugal
Investigational Site Number 620007
Penafiel, 4564-007, Portugal
Investigational Site Number 620006
Porto, 4200, Portugal
Investigational Site Number 642029
Arad, 310158, Romania
Investigational Site Number 642020
Baia Mare, 430123, Romania
Investigational Site Number 642003
Brasov, 500365, Romania
Investigational Site Number 642019
Brăila, 810249, Romania
Investigational Site Number 642034
Bucharest, 010825, Romania
Investigational Site Number 642022
Bucharest, 020475, Romania
Investigational Site Number 642001
Bucharest, 021392, Romania
Investigational Site Number 642013
Bucharest, 050098, Romania
Investigational Site Number 642026
Cluj-Napoca, 40001, Romania
Investigational Site Number 642030
Craiova, 200147, Romania
Investigational Site Number 642015
Craiova, 200642, Romania
Investigational Site Number 642007
Deva, 330084, Romania
Investigational Site Number 642011
Iași, 700547, Romania
Investigational Site Number 642010
Iași, 700732, Romania
Investigational Site Number 642016
Oradea, 410598, Romania
Investigational Site Number 642033
Piteşti, 110084, Romania
Investigational Site Number 642002
Ploieşti, 100097, Romania
Investigational Site Number 642009
Suceava, 720262, Romania
Investigational Site Number 642014
Târgu Mureş, 540099, Romania
Investigational Site Number 642012
Târgu Mureş, 540142, Romania
Investigational Site Number 642018
Timișoara, 300174, Romania
Investigational Site Number 642031
Timișoara, 300736, Romania
Investigational Site Number 643023
Barnaul, 656055, Russia
Investigational Site Number 643044
Kazan', 420012, Russia
Investigational Site Number 643005
Kemerovo, 650002, Russia
Investigational Site Number 643006
Kemerovo, 650002, Russia
Investigational Site Number 643061
Krasnodar, 350063, Russia
Investigational Site Number 643027
Krasnodar, 350086, Russia
Investigational Site Number 643037
Moscow, 101990, Russia
Investigational Site Number 643038
Moscow, 101990, Russia
Investigational Site Number 643002
Moscow, 105066, Russia
Investigational Site Number 643043
Moscow, 117036, Russia
Investigational Site Number 643008
Moscow, 117292, Russia
Investigational Site Number 643009
Moscow, 117292, Russia
Investigational Site Number 643029
Moscow, 117556, Russia
Investigational Site Number 643018
Moscow, 119048, Russia
Investigational Site Number 643042
Moscow, 119435, Russia
Investigational Site Number 643052
Moscow, 121309, Russia
Investigational Site Number 643026
Moscow, 121374, Russia
Investigational Site Number 643003
Moscow, 121552, Russia
Investigational Site Number 643051
Moscow, 125284, Russia
Investigational Site Number 643013
Moscow, 127018, Russia
Investigational Site Number 643001
Moscow, 127473, Russia
Investigational Site Number 643060
Moscow, 127644, Russia
Investigational Site Number 643040
Moscow, 129327, Russia
Investigational Site Number 643034
Nizhny Novgorod, 603003, Russia
Investigational Site Number 643054
Novosibirsk, 630047, Russia
Investigational Site Number 643055
Novosibirsk, 630075, Russia
Investigational Site Number 643045
Omsk, 644043, Russia
Investigational Site Number 643030
Penza, 440026, Russia
Investigational Site Number 643017
Perm, 614077, Russia
Investigational Site Number 643049
Perm, 614097, Russia
Investigational Site Number 643048
Rostov-on-Don, 344068, Russia
Investigational Site Number 643047
Ryazan, 390026, Russia
Investigational Site Number 643024
Saint Petersburg, 190000, Russia
Investigational Site Number 643031
Saint Petersburg, 192242, Russia
Investigational Site Number 643035
Saint Petersburg, 193312, Russia
Investigational Site Number 643022
Saint Petersburg, 194044, Russia
Investigational Site Number 643039
Saint Petersburg, 194156, Russia
Investigational Site Number 643057
Saint Petersburg, 194354, Russia
Investigational Site Number 643041
Saint Petersburg, 195257, Russia
Investigational Site Number 643036
Saint Petersburg, 197341, Russia
Investigational Site Number 643011
Saint Petersburg, 198013, Russia
Investigational Site Number 643004
Saint Petersburg, 199106, Russia
Investigational Site Number 643025
Saratov, 410028, Russia
Investigational Site Number 643056
Saratov, 410028, Russia
Investigational Site Number 643010
Saratov, 410030, Russia
Investigational Site Number 643033
Saratov, 410039, Russia
Investigational Site Number 643019
Saratov, 410054, Russia
Investigational Site Number 643014
Smolensk, 214018, Russia
Investigational Site Number 643028
Tomsk, 634012, Russia
Investigational Site Number 643016
Tver', 170036, Russia
Investigational Site Number 643012
Tyumen, 625023, Russia
Investigational Site Number 643059
Vladimir, 600020, Russia
Investigational Site Number 643058
Voronezh, 394065, Russia
Investigational Site Number 643020
Yaroslavl, 150003, Russia
Investigational Site Number 643062
Yaroslavl, 150030, Russia
Investigational Site Number 688002
Belgrade, 11000, Serbia
Investigational Site Number 688003
Belgrade, 11000, Serbia
Investigational Site Number 688004
Belgrade, 11000, Serbia
Investigational Site Number 688006
Belgrade, 11000, Serbia
Investigational Site Number 688008
Belgrade, 11000, Serbia
Investigational Site Number 688009
Belgrade, 11000, Serbia
Investigational Site Number 688010
Belgrade, 11000, Serbia
Investigational Site Number 688001
Belgrade, 11040, Serbia
Investigational Site Number 688005
Niš, 18000, Serbia
Investigational Site Number 688007
Niš, 18000, Serbia
Investigational Site Number 710020
Alberton, 1450, South Africa
Investigational Site Number 710017
Cape Town, 7405, South Africa
Investigational Site Number 710006
Cape Town, 7530, South Africa
Investigational Site Number 710010
Cape Town, 7764, South Africa
Investigational Site Number 710025
Cape Town, 7925, South Africa
Investigational Site Number 710008
Chatsworth, 4091, South Africa
Investigational Site Number 710011
Durban, South Africa
Investigational Site Number 710015
George, 6529, South Africa
Investigational Site Number 710019
Kempton Park, 1619, South Africa
Investigational Site Number 710014
Paarl, 7646, South Africa
Investigational Site Number 710023
Parow, 7500, South Africa
Investigational Site Number 710002
Pretoria, 0002, South Africa
Investigational Site Number 710001
Pretoria, 181, South Africa
Investigational Site Number 710005
Richards Bay, 3900, South Africa
Investigational Site Number 710007
Somerset West, 7130, South Africa
Investigational Site Number 710004
Worcester, 6850, South Africa
Investigational Site Number 410012
Bucheon-si, 420-767, South Korea
Investigational Site Number 410006
Daegu, 705-717, South Korea
Investigational Site Number 410009
Gwangju, 501-757, South Korea
Investigational Site Number 410008
Incheon, 400-711, South Korea
Investigational Site Number 410001
Incheon, 405-760, South Korea
Investigational Site Number 410004
Seongnam, 463-707, South Korea
Investigational Site Number 410014
Seoul, 110-744, South Korea
Investigational Site Number 410013
Seoul, 134-727, South Korea
Investigational Site Number 410002
Seoul, 135-720, South Korea
Investigational Site Number 410011
Seoul, 152-703, South Korea
Investigational Site Number 410010
Seoul, 156-755, South Korea
Investigational Site Number 410007
Wŏnju, 220-701, South Korea
Investigational Site Number 724013
A Coruña, 15006, Spain
Investigational Site Number 724005
Alcalá de Henares, 28805, Spain
Investigational Site Number 724016
Almería, 04120, Spain
Investigational Site Number 724012
Barakaldo, 48903, Spain
Investigational Site Number 724018
Barcelona, 08036, Spain
Investigational Site Number 724014
Bilbao, 48013, Spain
Investigational Site Number 724015
Cáceres, 10003, Spain
Investigational Site Number 724008
Lleida, 25198, Spain
Investigational Site Number 724011
Madrid, 28046, Spain
Investigational Site Number 724017
Murcia, 30120, Spain
Investigational Site Number 724022
Oviedo, 33006, Spain
Investigational Site Number 724003
Pontevedra, 36071, Spain
Investigational Site Number 724001
Seville, 41014, Spain
Investigational Site Number 724020
Valencia, 46010, Spain
Investigational Site Number 724004
Vigo, 36211, Spain
Investigational Site Number 752012
Karlstad, 651 85, Sweden
Investigational Site Number 752011
Kristianstad, 29185, Sweden
Investigational Site Number 752006
Ljungby, 341 82, Sweden
Investigational Site Number 752009
Oskarshamn, 572 28, Sweden
Investigational Site Number 752004
Stockholm, 118 83, Sweden
Investigational Site Number 752007
Stockholm, 182 88, Sweden
Investigational Site Number 752002
Vaxjo, 351 85, Sweden
Investigational Site Number 756003
Lugano, 6900, Switzerland
Investigational Site Number 158005
Chiayi City, 60002, Taiwan
Investigational Site Number 158004
Taichung, 402, Taiwan
Investigational Site Number 158006
Tainan Hsien, 710, Taiwan
Investigational Site Number 158002
Taipei, 100, Taiwan
Investigational Site Number 158007
Taipei, 111, Taiwan
Investigational Site Number 158001
Taipei, 112, Taiwan
Investigational Site Number 158008
Taipei, 220, Taiwan
Investigational Site Number 158003
Taipei Hsien, 23137, Taiwan
Investigational Site Number 788003
Sfax, 3029, Tunisia
Investigational Site Number 788005
Tunis, 1006, Tunisia
Investigational Site Number 788004
Tunis, 1007, Tunisia
Investigational Site Number 788002
Tunis, 1008, Tunisia
Investigational Site Number 788001
Tunis, 1027, Tunisia
Investigational Site Number 792004
Ankara, 06110, Turkey (Türkiye)
Investigational Site Number 792002
Ankara, 06490, Turkey (Türkiye)
Investigational Site Number 792012
Ankara, Turkey (Türkiye)
Investigational Site Number 792001
Capa / Istanbul, 34390, Turkey (Türkiye)
Investigational Site Number 792015
Istanbul, 34010, Turkey (Türkiye)
Investigational Site Number 792008
Istanbul, 34034, Turkey (Türkiye)
Investigational Site Number 792014
Istanbul, 34385, Turkey (Türkiye)
Investigational Site Number 792003
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number 792007
Izmir, 35100, Turkey (Türkiye)
Investigational Site Number 792011
Mersin, 33169, Turkey (Türkiye)
Investigational Site Number 792013
Samsun, 55200, Turkey (Türkiye)
Investigational Site Number 804004
Chernivtsi, 58022, Ukraine
Investigational Site Number 804006
Dnipro, 49023, Ukraine
Investigational Site Number 804002
Dnipropetrovsk, 49006, Ukraine
Investigational Site Number 804009
Kharkiv, 61022, Ukraine
Investigational Site Number 804010
Kharkiv, 61176, Ukraine
Investigational Site Number 804003
Kiev, 02091, Ukraine
Investigational Site Number 804011
Kiev, 02660, Ukraine
Investigational Site Number 804012
Kyiv, 03680, Ukraine
Investigational Site Number 804013
Kyiv, 04114, Ukraine
Investigational Site Number 804005
Lviv, 79015, Ukraine
Investigational Site Number 804007
Odesa, 65025, Ukraine
Investigational Site Number 804008
Odesa, 65059, Ukraine
Investigational Site Number 784001
Abu Dhabi, 51900, United Arab Emirates
Investigational Site Number 784002
Dubai, 4545, United Arab Emirates
Investigational Site Number 826042
Antrim, BT41 2RL, United Kingdom
Investigational Site Number 826002
Ashton-under-Lyne, OL6 9RW, United Kingdom
Investigational Site Number 826026
Barnstaple, EX31 4JB, United Kingdom
Investigational Site Number 826017
Bath, BA1 3NG, United Kingdom
Investigational Site Number 826034
Birmingham, B9 5SS, United Kingdom
Investigational Site Number 826052
Bolton, BL1 4AL, United Kingdom
Investigational Site Number 826005
Bradford, BD5 0NA, United Kingdom
Investigational Site Number 826048
Carmarthen, SA31 2AF, United Kingdom
Investigational Site Number 826037
Chester, CH2 1UL, United Kingdom
Investigational Site Number 826011
Dumfries, DG1 4AP, United Kingdom
Investigational Site Number 826044
East Kilbride, G75 8RG, United Kingdom
Investigational Site Number 826023
Edinburgh, EH3 9YW, United Kingdom
Investigational Site Number 826008
Glasgow, G11 6NT, United Kingdom
Investigational Site Number 826010
Harrogate, HG2 7SX, United Kingdom
Investigational Site Number 826040
Ipswich, IP4 5PD, United Kingdom
Investigational Site Number 826033
Larbert, FK5 4WR, United Kingdom
Investigational Site Number 826027
Liverpool, L9 7AL, United Kingdom
Investigational Site Number 826039
Londonderry, BT47 6SB, United Kingdom
Investigational Site Number 826036
Manchester, M13 9WL, United Kingdom
Investigational Site Number 826021
Manchester, M23 9LT, United Kingdom
Investigational Site Number 826006
Manchester, M8 6RB, United Kingdom
Investigational Site Number 826049
Norwich, NR1 3SR, United Kingdom
Investigational Site Number 826020
Nuneaton, CV10 7DJ, United Kingdom
Investigational Site Number 826009
Oldham, OL1 2JH, United Kingdom
Investigational Site Number 826007
Salford, M6 8HD, United Kingdom
Investigational Site Number 826045
Stoke-on-Trent, ST4 6QG, United Kingdom
Investigational Site Number 826038
Swansea, SA6 6NL, United Kingdom
Investigational Site Number 826018
Taunton, TA1 5DA, United Kingdom
Investigational Site Number 826016
Truro, TR1 3LJ, United Kingdom
Investigational Site Number 826046
Wolverhampton, WV10 0QP, United Kingdom
Investigational Site Number 826019
Yeovil, BA21 4AT, United Kingdom
Related Publications (12)
Bentley-Lewis R, Aguilar D, Riddle MC, Claggett B, Diaz R, Dickstein K, Gerstein HC, Johnston P, Kober LV, Lawson F, Lewis EF, Maggioni AP, McMurray JJ, Ping L, Probstfield JL, Solomon SD, Tardif JC, Wu Y, Pfeffer MA; ELIXA Investigators. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. Am Heart J. 2015 May;169(5):631-638.e7. doi: 10.1016/j.ahj.2015.02.002. Epub 2015 Feb 12.
PMID: 25965710BACKGROUNDPfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJ, Probstfield JL, Riddle MC, Solomon SD, Tardif JC; ELIXA Investigators. Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome. N Engl J Med. 2015 Dec 3;373(23):2247-57. doi: 10.1056/NEJMoa1509225.
PMID: 26630143RESULTNatale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
PMID: 39963952DERIVEDGerstein HC, Wolsk E, Claggett B, Diaz R, Dickstein K, Hess S, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Effect of lixisenatide on natriuretic peptides in people with type 2 diabetes and recent acute coronary syndrome: The ELIXA trial. Diabetes Obes Metab. 2023 Apr;25(4):1125-1129. doi: 10.1111/dom.14954. Epub 2023 Jan 3. No abstract available.
PMID: 36546588DERIVEDGerstein HC, Hess S, Claggett B, Dickstein K, Kober L, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Pfeffer MA. Protein Biomarkers and Cardiovascular Outcomes in People With Type 2 Diabetes and Acute Coronary Syndrome: The ELIXA Biomarker Study. Diabetes Care. 2022 Sep 1;45(9):2152-2155. doi: 10.2337/dc22-0453.
PMID: 35817031DERIVEDWijkman MO, Claggett B, Diaz R, Gerstein HC, Kober L, Lewis E, Maggioni AP, Wolsk E, Aguilar D, Bentley-Lewis R, McMurray JJ, Probstfield J, Riddle M, Tardif JC, Solomon SD, Pfeffer MA. Blood pressure and mortality in patients with type 2 diabetes and a recent coronary event in the ELIXA trial. Cardiovasc Diabetol. 2020 Oct 12;19(1):175. doi: 10.1186/s12933-020-01150-0.
PMID: 33046070DERIVEDShin SH, Claggett B, Pfeffer MA, Skali H, Liu J, Aguilar D, Diaz R, Dickstein K, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Tardif JC, Solomon SD; ELIXA Investigators. Hyperglycaemia, ejection fraction and the risk of heart failure or cardiovascular death in patients with type 2 diabetes and a recent acute coronary syndrome. Eur J Heart Fail. 2020 Jul;22(7):1133-1143. doi: 10.1002/ejhf.1790. Epub 2020 Mar 25.
PMID: 32212368DERIVEDSeferovic JP, Bentley-Lewis R, Claggett B, Diaz R, Gerstein HC, Kober LV, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Pfeffer MA. Retinopathy, Neuropathy, and Subsequent Cardiovascular Events in Patients with Type 2 Diabetes and Acute Coronary Syndrome in the ELIXA: The Importance of Disease Duration. J Diabetes Res. 2018 Dec 16;2018:1631263. doi: 10.1155/2018/1631263. eCollection 2018.
PMID: 30648112DERIVEDMuskiet MHA, Tonneijck L, Huang Y, Liu M, Saremi A, Heerspink HJL, van Raalte DH. Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 Nov;6(11):859-869. doi: 10.1016/S2213-8587(18)30268-7. Epub 2018 Oct 3.
PMID: 30292589DERIVEDWittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population. Am J Manag Care. 2018 Apr;24(8 Suppl):S146-S155.
PMID: 29693361DERIVEDWolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC, Kober L. Role of B-Type Natriuretic Peptide and N-Terminal Prohormone BNP as Predictors of Cardiovascular Morbidity and Mortality in Patients With a Recent Coronary Event and Type 2 Diabetes Mellitus. J Am Heart Assoc. 2017 May 29;6(6):e004743. doi: 10.1161/JAHA.116.004743.
PMID: 28554908DERIVEDWohlfart P, Linz W, Hubschle T, Linz D, Huber J, Hess S, Crowther D, Werner U, Ruetten H. Cardioprotective effects of lixisenatide in rat myocardial ischemia-reperfusion injury studies. J Transl Med. 2013 Mar 28;11:84. doi: 10.1186/1479-5876-11-84.
PMID: 23537041DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trail Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
June 1, 2010
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
December 20, 2016
Results First Posted
October 14, 2016
Record last verified: 2016-10