Clinical trial NCT01147250: Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 6068
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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

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

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

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

Primary outcomes:
measure: Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina
timeFrame: From randomization up to the end of study (median follow-up of 25 months)
Secondary outcomes:
measure: Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
timeFrame: From randomization up to the end of study (median follow-up of 25 months)
measure: 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
timeFrame: From randomization up to the end of study (median follow-up of 25 months)
measure: Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108
timeFrame: Baseline to Week 108 (LOCF)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840415
state: Alabama
city: Foley
country: United States
facility: Investigational Site Number 840307
state: Alabama
city: Mobile
country: United States
facility: Investigational Site Number 840692
state: Alabama
city: Mobile
country: United States
facility: Investigational Site Number 840037
state: Alabama
city: Mobile
country: United States
facility: Investigational Site Number 840210
state: Alabama
city: Muscle Shoals
country: United States
facility: Investigational Site Number 840326
state: Alabama
city: Toney
country: United States
facility: Investigational Site Number 840393
state: Alabama
city: Mesa
country: United States
facility: Investigational Site Number 840656
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840506
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840520
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840322
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840250
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840042
state: Arizona
city: Hot Springs
country: United States
facility: Investigational Site Number 840303
state: Arkansas
city: Jonesboro
country: United States
facility: Investigational Site Number 840184
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840361
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site Number 840023
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site Number 840706
state: California
city: Anaheim
country: United States
facility: Investigational Site Number 840497
state: California
city: Downey
country: United States
facility: Investigational Site Number 840667
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840150
state: California
city: Hawthorne
country: United States
facility: Investigational Site Number 840624
state: California
city: Inglewood
country: United States
facility: Investigational Site Number 840623
state: California
city: Inglewood
country: United States
facility: Investigational Site Number 840636
state: California
city: La Mesa
country: United States
facility: Investigational Site Number 840455
state: California
city: Loma Linda
country: United States
facility: Investigational Site Number 840240
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840262
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840606
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840694
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840431
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840135
state: California
city: Merced
country: United States
facility: Investigational Site Number 840314
state: California
city: Mission Viejo
country: United States
facility: Investigational Site Number 840290
state: California
city: National City
country: United States
facility: Investigational Site Number 840592
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840275
state: California
city: Oakland
country: United States
facility: Investigational Site Number 840654
state: California
city: Orange
country: United States
facility: Investigational Site Number 840351
state: California
city: Orange
country: United States
facility: Investigational Site Number 840689
state: California
city: Pomona
country: United States
facility: Investigational Site Number 840582
state: California
city: Port Hueneme
country: United States
facility: Investigational Site Number 840346
state: California
city: Roseville
country: United States
facility: Investigational Site Number 840466
state: California
city: San Marino
country: United States
facility: Investigational Site Number 840575
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840131
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840335
state: California
city: Simi Valley
country: United States
facility: Investigational Site Number 840576
state: California
city: Sylmar
country: United States
facility: Investigational Site Number 840414
state: California
city: Ventura
country: United States
facility: Investigational Site Number 840395
state: California
city: Vista
country: United States
facility: Investigational Site Number 840206
state: California
city: Westlake Village
country: United States
facility: Investigational Site Number 840480
state: California
city: Whittier
country: United States
facility: Investigational Site Number 840350
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840093
state: Colorado
city: Washington
country: United States
facility: Investigational Site Number 840631
state: District of Columbia
city: Washington
country: United States
facility: Investigational Site Number 840044
state: District of Columbia
city: Clearwater
country: United States
facility: Investigational Site Number 840281
state: Florida
city: Homosassa
country: United States
facility: Investigational Site Number 840477
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840261
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840459
state: Florida
city: Oviedo
country: United States
facility: Investigational Site Number 840432
state: Florida
city: Panama City
country: United States
facility: Investigational Site Number 840318
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site Number 840056
state: Florida
city: Wellington
country: United States
facility: Investigational Site Number 840295
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840066
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number 840446
state: Georgia
city: Atlanta
country: United States
facility: Investigational Site Number 840487
state: Georgia
city: Blue Ridge
country: United States
facility: Investigational Site Number 840578
state: Georgia
city: Columbus
country: United States
facility: Investigational Site Number 840534
state: Georgia
city: Duluth
country: United States
facility: Investigational Site Number 840447
state: Georgia
city: Duluth
country: United States
facility: Investigational Site Number 840499
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840536
state: Idaho
city: Pocatello
country: United States
facility: Investigational Site Number 840413
state: Idaho
city: Arlington Heights
country: United States
facility: Investigational Site Number 840519
state: Illinois
city: Belleville
country: United States
facility: Investigational Site Number 840589
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840107
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840633
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840663
state: Illinois
city: Hines
country: United States
facility: Investigational Site Number 840212
state: Illinois
city: Joliet
country: United States
facility: Investigational Site Number 840345
state: Illinois
city: Peoria
country: United States
facility: Investigational Site Number 840681
state: Illinois
city: Elwood
country: United States
facility: Investigational Site Number 840360
state: Indiana
city: Gary
country: United States
facility: Investigational Site Number 840676
state: Indiana
city: Hammond
country: United States
facility: Investigational Site Number 840657
state: Indiana
city: Huntington
country: United States
facility: Investigational Site Number 840621
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840702
state: Indiana
city: Topeka
country: United States
facility: Investigational Site Number 840009
state: Kansas
city: Covington
country: United States
facility: Investigational Site Number 840533
state: Kentucky
city: Madisonville
country: United States
facility: Investigational Site Number 840251
state: Kentucky
city: Owensboro
country: United States
facility: Investigational Site Number 840168
state: Kentucky
city: Pikeville
country: United States
facility: Investigational Site Number 840449
state: Kentucky
city: Baton Rouge
country: United States
facility: Investigational Site Number 840299
state: Louisiana
city: Hammond
country: United States
facility: Investigational Site Number 840671
state: Louisiana
city: Metairie
country: United States
facility: Investigational Site Number 840470
state: Louisiana
city: Shreveport
country: United States
facility: Investigational Site Number 840178
state: Louisiana
city: Annapolis
country: United States
facility: Investigational Site Number 840043
state: Maryland
city: Catonsville
country: United States
facility: Investigational Site Number 840639
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840430
state: Maryland
city: Takoma Park
country: United States
facility: Investigational Site Number 840640
state: Maryland
city: Towson
country: United States
facility: Investigational Site Number 840293
state: Maryland
city: Alpena
country: United States
facility: Investigational Site Number 840019
state: Michigan
city: Buckley
country: United States
facility: Investigational Site Number 840352
state: Michigan
city: Chesterfield
country: United States
facility: Investigational Site Number 840555
state: Michigan
city: Dearborn
country: United States
facility: Investigational Site Number 840411
state: Michigan
city: Detroit
country: United States
facility: Investigational Site Number 840205
state: Michigan
city: Flint
country: United States
facility: Investigational Site Number 840581
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840404
state: Michigan
city: Southfield
country: United States
facility: Investigational Site Number 840312
state: Michigan
city: Sterling Heights
country: United States
facility: Investigational Site Number 840484
state: Michigan
city: Duluth
country: United States
facility: Investigational Site Number 840219
state: Minnesota
city: Eagan
country: United States
facility: Investigational Site Number 840199
state: Minnesota
city: Biloxi
country: United States
facility: Investigational Site Number 840196
state: Mississippi
city: Kansas City
country: United States
facility: Investigational Site Number 840445
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site Number 840008
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840091
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840046
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840678
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840400
state: Missouri
city: Kalispell
country: United States
facility: Investigational Site Number 840337
state: Montana
city: Lincoln
country: United States
facility: Investigational Site Number 840509
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840007
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 840382
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840680
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840217
state: Nevada
city: Linden
country: United States
facility: Investigational Site Number 840072
state: New Jersey
city: Ridgewood
country: United States
facility: Investigational Site Number 840628
state: New Jersey
city: Somerset
country: United States
facility: Investigational Site Number 840162
state: New Jersey
city: Albany
country: United States
facility: Investigational Site Number 840285
state: New York
city: Jamaica
country: United States
facility: Investigational Site Number 840585
state: New York
city: Mineola
country: United States
facility: Investigational Site Number 840348
state: New York
city: Northport
country: United States
facility: Investigational Site Number 840119
state: New York
city: Rosedale
country: United States
facility: Investigational Site Number 840696
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840310
state: North Carolina
city: Calabash
country: United States
facility: Investigational Site Number 840454
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840672
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840152
state: North Carolina
city: Elizabeth City
country: United States
facility: Investigational Site Number 840344
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840328
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840513
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840504
state: North Carolina
city: Monroe
country: United States
facility: Investigational Site Number 840642
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site Number 840481
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840381
state: North Carolina
city: Winston Salem
country: United States
facility: Investigational Site Number 840532
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site Number 840028
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site Number 840198
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 840543
state: Ohio
city: Dayton
country: United States
facility: Investigational Site Number 840456
state: Ohio
city: Marion
country: United States
facility: Investigational Site Number 840368
state: Ohio
city: Bend
country: United States
facility: Investigational Site Number 840427
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840422
state: Oregon
city: Portland
country: United States
facility: Investigational Site Number 840511
state: Oregon
city: Butler
country: United States
facility: Investigational Site Number 840560
state: Pennsylvania
city: Clark Summit
country: United States
facility: Investigational Site Number 840464
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840401
state: Pennsylvania
city: Providence
country: United States
facility: Investigational Site Number 840266
state: Rhode Island
city: Anderson
country: United States
facility: Investigational Site Number 840223
state: South Carolina
city: Columbia
country: United States
facility: Investigational Site Number 840353
state: South Carolina
city: Green Ville
country: United States
facility: Investigational Site Number 840529
state: South Carolina
city: Greer
country: United States
facility: Investigational Site Number 840550
state: South Carolina
city: Myrtle Beach
country: United States
facility: Investigational Site Number 840258
state: South Carolina
city: Taylors
country: United States
facility: Investigational Site Number 840309
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site Number 840551
state: South Dakota
city: Bartlett
country: United States
facility: Investigational Site Number 840524
state: Tennessee
city: Chattanooga
country: United States
facility: Investigational Site Number 840308
state: Tennessee
city: Germantown
country: United States
facility: Investigational Site Number 840047
state: Tennessee
city: Jackson
country: United States
facility: Investigational Site Number 840313
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site Number 840625
state: Tennessee
city: Memphis
country: United States
facility: Investigational Site Number 840637
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site Number 840096
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site Number 840388
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site Number 840473
state: Texas
city: Edinburg
country: United States
facility: Investigational Site Number 840677
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840698
state: Texas
city: Fair Oaks Ranch
country: United States
facility: Investigational Site Number 840439
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840164
state: Texas
city: Longview
country: United States
facility: Investigational Site Number 840545
state: Texas
city: Lubbock
country: United States
facility: Investigational Site Number 840385
state: Texas
city: Lubbock
country: United States
facility: Investigational Site Number 840530
state: Texas
city: Marshall
country: United States
facility: Investigational Site Number 840174
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840565
state: Texas
city: Richmond
country: United States
facility: Investigational Site Number 840608
state: Texas
city: San Antonio
country: United States
facility: Investigational Site Number 840573
state: Texas
city: Sugarland
country: United States
facility: Investigational Site Number 840564
state: Texas
city: Waco
country: United States
facility: Investigational Site Number 840241
state: Texas
city: American Fork
country: United States
facility: Investigational Site Number 840232
state: Utah
city: Draper
country: United States
facility: Investigational Site Number 840471
state: Utah
city: Charlottesville
country: United States
facility: Investigational Site Number 840503
state: Virginia
city: Chesapeake
country: United States
facility: Investigational Site Number 840180
state: Virginia
city: Chesapeake
country: United States
facility: Investigational Site Number 840465
state: Virginia
city: Chesapeake
country: United States
facility: Investigational Site Number 840128
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840045
state: Virginia
city: Norfolk
country: United States
facility: Investigational Site Number 840213
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840001
state: Virginia
city: Roanoke
country: United States
facility: Investigational Site Number 840286
state: Virginia
city: Olympia
country: United States
facility: Investigational Site Number 840170
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840094
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840343
state: Washington
city: Spokane
country: United States
facility: Investigational Site Number 840268
state: Washington
city: Tacoma
country: United States
facility: Investigational Site Number 840061
state: Washington
city: Fairmount
country: United States
facility: Investigational Site Number 840613
state: Wisconsin
city: Lacrosse
country: United States
facility: Investigational Site Number 840121
state: Wisconsin
city: Milwaukee
country: United States
facility: Investigational Site Number 840493
state: Wisconsin
city: Adrogue
country: Argentina
facility: Investigational Site Number 032028
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number 032030
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number 032043
city: Bahia Blanca
country: Argentina
facility: Investigational Site Number 032054
city: Caba
country: Argentina
facility: Investigational Site Number 032066
city: Caba
country: Argentina
facility: Investigational Site Number 032049
city: Caba
country: Argentina
facility: Investigational Site Number 032056
city: Caba
country: Argentina
facility: Investigational Site Number 032003
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032017
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032009
city: Cipolletti
country: Argentina
facility: Investigational Site Number 032050
city: Ciudad Autonoma De Bs.As
country: Argentina
facility: Investigational Site Number 032052
city: Cordoba
country: Argentina
facility: Investigational Site Number 032011
city: Cordoba
country: Argentina
facility: Investigational Site Number 032022
city: Cordoba
country: Argentina
facility: Investigational Site Number 032037
city: Coronel Suarez
country: Argentina
facility: Investigational Site Number 032020
city: Corrientes
country: Argentina
facility: Investigational Site Number 032004
city: Corrientes
country: Argentina
facility: Investigational Site Number 032018
city: Córdoba
country: Argentina
facility: Investigational Site Number 032015
city: Godoy Cruz
country: Argentina
facility: Investigational Site Number 032005
city: Haedo
country: Argentina
facility: Investigational Site Number 032042
city: Junin
country: Argentina
facility: Investigational Site Number 032019
city: La Plata
country: Argentina
facility: Investigational Site Number 032063
city: Lanus
country: Argentina
facility: Investigational Site Number 032040
city: Mar Del Plata
country: Argentina
facility: Investigational Site Number 032036
city: Mar Del Plata
country: Argentina
facility: Investigational Site Number 032039
city: Mendoza
country: Argentina
facility: Investigational Site Number 032058
city: Moron
country: Argentina
facility: Investigational Site Number 032038
city: Parana
country: Argentina
facility: Investigational Site Number 032002
city: Qilmes
country: Argentina
facility: Investigational Site Number 032023
city: Rafaela
country: Argentina
facility: Investigational Site Number 032047
city: Ramos Mejia
country: Argentina
facility: Investigational Site Number 032024
city: Resistencia
country: Argentina
facility: Investigational Site Number 032006
city: Rosario
country: Argentina
facility: Investigational Site Number 032012
city: Rosario
country: Argentina
facility: Investigational Site Number 032027
city: Salta
country: Argentina
facility: Investigational Site Number 032055
city: Salta
country: Argentina
facility: Investigational Site Number 032065
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032051
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032008
city: San Nicolas
country: Argentina
facility: Investigational Site Number 032033
city: Santa Fe
country: Argentina
facility: Investigational Site Number 032045
city: Santa Fe
country: Argentina
facility: Investigational Site Number 032035
city: Santa Rosa
country: Argentina
facility: Investigational Site Number 032062
city: Venado Tuerto
country: Argentina
facility: Investigational Site Number 032034
city: Villa Maria
country: Argentina
facility: Investigational Site Number 032046
city: Zarate
country: Argentina
facility: Investigational Site Number 032029
city: Epping
country: Australia
facility: Investigational Site Number 036015
city: Fremantle
country: Australia
facility: Investigational Site Number 036001
city: Geelong
country: Australia
facility: Investigational Site Number 036009
city: Perth
country: Australia
facility: Investigational Site Number 036011
city: St Leonards
country: Australia
facility: Investigational Site Number 036005
city: Townsville
country: Australia
facility: Investigational Site Number 036016
city: Graz
country: Austria
facility: Investigational Site Number 040002
city: Wien
country: Austria
facility: Investigational Site Number 040001
city: Minsk
country: Belarus
facility: Investigational Site Number 112002
city: Minsk
country: Belarus
facility: Investigational Site Number 112003
city: Minsk
country: Belarus
facility: Investigational Site Number 112001
city: Bruxelles
country: Belgium
facility: Investigational Site Number 056001
city: Leuven
country: Belgium
facility: Investigational Site Number 056003
city: Belem
country: Brazil
facility: Investigational Site Number 076024
city: Belo Horizonte
country: Brazil
facility: Investigational Site Number 076006
city: Belo Horizonte
country: Brazil
facility: Investigational Site Number 076012
city: Brasilia
country: Brazil
facility: Investigational Site Number 076021
city: Campinas
country: Brazil
facility: Investigational Site Number 076002
city: Curitiba
country: Brazil
facility: Investigational Site Number 076019
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076003
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076018
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076004
city: Goiania
country: Brazil
facility: Investigational Site Number 076023
city: Marilia
country: Brazil
facility: Investigational Site Number 076014
city: Passo Fundo
country: Brazil
facility: Investigational Site Number 076015
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076008
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076013
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076026
city: Recife
country: Brazil
facility: Investigational Site Number 076025
city: Salvador
country: Brazil
facility: Investigational Site Number 076020
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076016
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076010
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076001
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076005
city: Uberlandia
country: Brazil
facility: Investigational Site Number 076007
city: Byala
country: Bulgaria
facility: Investigational Site Number 100002
city: Gabrovo
country: Bulgaria
facility: Investigational Site Number 100011
city: Kazanluk
country: Bulgaria
facility: Investigational Site Number 100001
city: Lovech
country: Bulgaria
facility: Investigational Site Number 100006
city: Pleven
country: Bulgaria
facility: Investigational Site Number 100004
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100003
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100007
city: Sandanski
country: Bulgaria
facility: Investigational Site Number 100016
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100010
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100015
city: Varna
country: Bulgaria
facility: Investigational Site Number 100005
city: Calgary
country: Canada
facility: Investigational Site Number 124024
city: Cambridge
country: Canada
facility: Investigational Site Number 124016
city: Edmonton
country: Canada
facility: Investigational Site Number 124026
city: Laval
country: Canada
facility: Investigational Site Number 124001
city: Montreal
country: Canada
facility: Investigational Site Number 124021
city: Montreal
country: Canada
facility: Investigational Site Number 124006
city: Oshawa
country: Canada
facility: Investigational Site Number 124027
city: Quebec
country: Canada
facility: Investigational Site Number 124025
city: Red Deer
country: Canada
facility: Investigational Site Number 124028
city: Sarnia
country: Canada
facility: Investigational Site Number 124007
city: St-Marc-Des-Carrieres
country: Canada
facility: Investigational Site Number 124003
city: Sudbury
country: Canada
facility: Investigational Site Number 124005
city: Thetford Mines
country: Canada
facility: Investigational Site Number 124002
city: Antofagasta
country: Chile
facility: Investigational Site Number 152024
city: Concepcion
country: Chile
facility: Investigational Site Number 152023
city: Osorno
country: Chile
facility: Investigational Site Number 152041
city: Puerto Montt
country: Chile
facility: Investigational Site Number 152040
city: Punta Arenas
country: Chile
facility: Investigational Site Number 152038
city: San Felipe
country: Chile
facility: Investigational Site Number 152036
city: Santiago
country: Chile
facility: Investigational Site Number 152035
city: Santiago
country: Chile
facility: Investigational Site Number 152020
city: Santiago
country: Chile
facility: Investigational Site Number 152028
city: Santiago
country: Chile
facility: Investigational Site Number 152031
city: Santiago
country: Chile
facility: Investigational Site Number 152001
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country: Chile
facility: Investigational Site Number 152034
city: Santiago
country: Chile
facility: Investigational Site Number 152008
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country: Chile
facility: Investigational Site Number 152013
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country: Chile
facility: Investigational Site Number 152019
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country: Chile
facility: Investigational Site Number 152018
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country: Chile
facility: Investigational Site Number 152042
city: Santiago
country: Chile
facility: Investigational Site Number 152015
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country: Chile
facility: Investigational Site Number 152004
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country: Chile
facility: Investigational Site Number 152029
city: Santiago
country: Chile
facility: Investigational Site Number 152022
city: Santiago
country: Chile
facility: Investigational Site Number 152011
city: Talca
country: Chile
facility: Investigational Site Number 152025
city: Temuco
country: Chile
facility: Investigational Site Number 152014
city: Temuco
country: Chile
facility: Investigational Site Number 152003
city: Valdivia
country: Chile
facility: Investigational Site Number 152037
city: Valparaíso
country: Chile
facility: Investigational Site Number 152032
city: Vina Del Mar
country: Chile
facility: Investigational Site Number 152002
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152010
city: Beijing
country: China
facility: Investigational Site Number 156016
city: Beijing
country: China
facility: Investigational Site Number 156034
city: Beijing
country: China
facility: Investigational Site Number 156024
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country: China
facility: Investigational Site Number 156028
city: Beijing
country: China
facility: Investigational Site Number 156014
city: Beijing
country: China
facility: Investigational Site Number 156005
city: Beijing
country: China
facility: Investigational Site Number 156006
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country: China
facility: Investigational Site Number 156001
city: Dalian
country: China
facility: Investigational Site Number 156008
city: Guangzhou
country: China
facility: Investigational Site Number 156020
city: Jinan
country: China
facility: Investigational Site Number 156023
city: Jinan
country: China
facility: Investigational Site Number 156015
city: Nanjing
country: China
facility: Investigational Site Number 156009
city: Shanghai
country: China
facility: Investigational Site Number 156013
city: Shanghai
country: China
facility: Investigational Site Number 156019
city: Shenyang
country: China
facility: Investigational Site Number 156032
city: Shenyang
country: China
facility: Investigational Site Number 156022
city: Suzhou
country: China
facility: Investigational Site Number 156004
city: Urumchi
country: China
facility: Investigational Site Number 156033
city: Armenia
country: Colombia
facility: Investigational Site Number 170025
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170009
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170010
city: Bogota
country: Colombia
facility: Investigational Site Number 170002
city: Bogota
country: Colombia
facility: Investigational Site Number 170005
city: Bogota
country: Colombia
facility: Investigational Site Number 170012
city: Bogota
country: Colombia
facility: Investigational Site Number 170014
city: Bogota
country: Colombia
facility: Investigational Site Number 170022
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170004
city: Cali
country: Colombia
facility: Investigational Site Number 170017
city: Cali
country: Colombia
facility: Investigational Site Number 170024
city: Cartagena
country: Colombia
facility: Investigational Site Number 170013
city: Espinal - Tolima
country: Colombia
facility: Investigational Site Number 170026
city: Floridablanca
country: Colombia
facility: Investigational Site Number 170007
city: Floridablanca
country: Colombia
facility: Investigational Site Number 170008
city: Manizales
country: Colombia
facility: Investigational Site Number 170019
city: Medellin
country: Colombia
facility: Investigational Site Number 170003
city: Medellin
country: Colombia
facility: Investigational Site Number 170020
city: Pereira
country: Colombia
facility: Investigational Site Number 170021
city: Aarhus C
country: Denmark
facility: Investigational Site Number 208009
city: Aarhus
country: Denmark
facility: Investigational Site Number 208003
city: Esbjerg
country: Denmark
facility: Investigational Site Number 208011
city: Farsø
country: Denmark
facility: Investigational Site Number 208004
city: Hellerup
country: Denmark
facility: Investigational Site Number 208002
city: Herlev
country: Denmark
facility: Investigational Site Number 208010
city: Hillerød
country: Denmark
facility: Investigational Site Number 208008
city: Hvidovre
country: Denmark
facility: Investigational Site Number 208006
city: København Nv
country: Denmark
facility: Investigational Site Number 208001
city: København S
country: Denmark
facility: Investigational Site Number 208005
city: København Ø
country: Denmark
facility: Investigational Site Number 208007
city: Guayaquil
country: Ecuador
facility: Investigational Site Number 218001
city: Guayaquil
country: Ecuador
facility: Investigational Site Number 218005
city: Quito
country: Ecuador
facility: Investigational Site Number 218002
city: Alexandria
country: Egypt
facility: Investigational Site Number 818002
city: Cairo
country: Egypt
facility: Investigational Site Number 818001
city: Tallinn
country: Estonia
facility: Investigational Site Number 233004
city: Tallinn
country: Estonia
facility: Investigational Site Number 233002
city: Tallinn
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facility: Investigational Site Number 233001
city: Tallinn
country: Estonia
facility: Investigational Site Number 233003
city: Tartu
country: Estonia
facility: Investigational Site Number 233005
city: Viljandimaa
country: Estonia
facility: Investigational Site Number 233006
city: Jyväskylä
country: Finland
facility: Investigational Site Number 246005
city: Rauma
country: Finland
facility: Investigational Site Number 246003
city: Tampere
country: Finland
facility: Investigational Site Number 246010
city: Turku
country: Finland
facility: Investigational Site Number 246009
city: Valkeakoski
country: Finland
facility: Investigational Site Number 246007
city: Vantaa
country: Finland
facility: Investigational Site Number 246012
city: Brest Cedex
country: France
facility: Investigational Site Number 250008
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250002
city: Nantes
country: France
facility: Investigational Site Number 250005
city: Nimes
country: France
facility: Investigational Site Number 250014
city: Paris Cedex 15
country: France
facility: Investigational Site Number 250007
city: Pessac
country: France
facility: Investigational Site Number 250011
city: Poitiers Cedex
country: France
facility: Investigational Site Number 250012
city: Rennes
country: France
facility: Investigational Site Number 250006
city: Toulouse Cedex 4
country: France
facility: Investigational Site Number 250001
city: Batumi
country: Georgia
facility: Investigational Site Number 268003
city: Kutaisi
country: Georgia
facility: Investigational Site Number 268004
city: Tbilisi
country: Georgia
facility: Investigational Site Number 268001
city: Tbilisi
country: Georgia
facility: Investigational Site Number 268002
city: Berlin
country: Germany
facility: Investigational Site Number 276003
city: Bochum
country: Germany
facility: Investigational Site Number 276022
city: Chemnitz
country: Germany
facility: Investigational Site Number 276005
city: Dresden
country: Germany
facility: Investigational Site Number 276021
city: Dresden
country: Germany
facility: Investigational Site Number 276024
city: Elsterwerda
country: Germany
facility: Investigational Site Number 276007
city: Frankfurt A.M.
country: Germany
facility: Investigational Site Number 276018
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276011
city: Görlitz
country: Germany
facility: Investigational Site Number 276017
city: Haßloch
country: Germany
facility: Investigational Site Number 276025
city: Heidelberg
country: Germany
facility: Investigational Site Number 276009
city: Leipzig
country: Germany
facility: Investigational Site Number 276019
city: Magdeburg
country: Germany
facility: Investigational Site Number 276020
city: Mühldorf Am Inn
country: Germany
facility: Investigational Site Number 276028
city: Pirna
country: Germany
facility: Investigational Site Number 276014
city: Pohlheim
country: Germany
facility: Investigational Site Number 276016
city: Rotenburg An Der Fulda
country: Germany
facility: Investigational Site Number 276026
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320004
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320006
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320012
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320014
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320001
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320002
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320007
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320008
city: Guatemala
country: Guatemala
facility: Investigational Site Number 320011
city: Quetzaltenango
country: Guatemala
facility: Investigational Site Number 320015
city: Ahmedabad
country: India
facility: Investigational Site Number 356019
city: Bangalore
country: India
facility: Investigational Site Number 356002
city: Bangalore
country: India
facility: Investigational Site Number 356010
city: Bangalore
country: India
facility: Investigational Site Number 356026
city: Belgaum
country: India
facility: Investigational Site Number 356024
city: Chandigarh
country: India
facility: Investigational Site Number 356012
city: Cochin
country: India
facility: Investigational Site Number 356016
city: Gurgaon
country: India
facility: Investigational Site Number 356022
city: Hubli
country: India
facility: Investigational Site Number 356029
city: Hyderabad
country: India
facility: Investigational Site Number 356020
city: Jaipur
country: India
facility: Investigational Site Number 356031
city: Kolkata
country: India
facility: Investigational Site Number 356004
city: Lucknow
country: India
facility: Investigational Site Number 356015
city: Lucknow
country: India
facility: Investigational Site Number 356014
city: Ludhiana
country: India
facility: Investigational Site Number 356009
city: Madurai
country: India
facility: Investigational Site Number 356025
city: Mangalore
country: India
facility: Investigational Site Number 356032
city: Manipal
country: India
facility: Investigational Site Number 356018
city: Mysore
country: India
facility: Investigational Site Number 356023
city: Nagpur
country: India
facility: Investigational Site Number 356027
city: Nagpur
country: India
facility: Investigational Site Number 356006
city: Nashik
country: India
facility: Investigational Site Number 356034
city: Nasik
country: India
facility: Investigational Site Number 356030
city: New Delhi
country: India
facility: Investigational Site Number 356013
city: New Delhi
country: India
facility: Investigational Site Number 356017
city: Pune
country: India
facility: Investigational Site Number 356021
city: Pune
country: India
facility: Investigational Site Number 356028
city: Afula
country: Israel
facility: Investigational Site Number 376010
city: Givatayim
country: Israel
facility: Investigational Site Number 376006
city: Haifa
country: Israel
facility: Investigational Site Number 376002
city: Haifa
country: Israel
facility: Investigational Site Number 376008
city: Holon
country: Israel
facility: Investigational Site Number 376001
city: Jerusalem
country: Israel
facility: Investigational Site Number 376012
city: Nahariya
country: Israel
facility: Investigational Site Number 376011
city: Safed
country: Israel
facility: Investigational Site Number 376005
city: Tel Aviv
country: Israel
facility: Investigational Site Number 376004
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376003
city: Tzrifin
country: Israel
facility: Investigational Site Number 376009
city: Carpi
country: Italy
facility: Investigational Site Number 380024
city: Chieri
country: Italy
facility: Investigational Site Number 380004
city: Chieti
country: Italy
facility: Investigational Site Number 380002
city: Fermo
country: Italy
facility: Investigational Site Number 380006
city: Firenze
country: Italy
facility: Investigational Site Number 380010
city: Genova
country: Italy
facility: Investigational Site Number 380009
city: Messina
country: Italy
facility: Investigational Site Number 380016
city: Milano
country: Italy
facility: Investigational Site Number 380023
city: Milano
country: Italy
facility: Investigational Site Number 380011
city: Milano
country: Italy
facility: Investigational Site Number 380012
city: Napoli
country: Italy
facility: Investigational Site Number 380014
city: Novara
country: Italy
facility: Investigational Site Number 380019
city: Palermo
country: Italy
facility: Investigational Site Number 380005
city: Pisa
country: Italy
facility: Investigational Site Number 380001
city: Roma
country: Italy
facility: Investigational Site Number 380013
city: Rozzano
country: Italy
facility: Investigational Site Number 380020
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392011
city: Fuchu-Shi
country: Japan
facility: Investigational Site Number 392015
city: Fujisawa-Shi
country: Japan
facility: Investigational Site Number 392012
city: Hachioji-Shi
country: Japan
facility: Investigational Site Number 392025
city: Hakusan-Shi
country: Japan
facility: Investigational Site Number 392027
city: Hamamatsu-Shi
country: Japan
facility: Investigational Site Number 392005
city: Hitachi-Shi
country: Japan
facility: Investigational Site Number 392022
city: Itabashi-Ku
country: Japan
facility: Investigational Site Number 392003
city: Itabashi-Ku
country: Japan
facility: Investigational Site Number 392017
city: Kawanishi-Shi
country: Japan
facility: Investigational Site Number 392019
city: Kobe-Shi
country: Japan
facility: Investigational Site Number 392013
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392007
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392008
city: Nagasaki-Shi
country: Japan
facility: Investigational Site Number 392009
city: Noda-Shi
country: Japan
facility: Investigational Site Number 392002
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392020
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392021
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392001
city: Sapporo-Shi
country: Japan
facility: Investigational Site Number 392010
city: Setagaya-Ku
country: Japan
facility: Investigational Site Number 392024
city: Shinagawa-Ku
country: Japan
facility: Investigational Site Number 392004
city: Shirakawa-Shi
country: Japan
facility: Investigational Site Number 392014
city: Suita-Shi
country: Japan
facility: Investigational Site Number 392018
city: Tachikawa-Shi
country: Japan
facility: Investigational Site Number 392016
city: Takasaki-Shi
country: Japan
facility: Investigational Site Number 392023
city: Bucheon
country: Korea, Republic of
facility: Investigational Site Number 410012
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 410009
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410014
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410013
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410011
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410010
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Cesis
country: Latvia
facility: Investigational Site Number 428005
city: Daugavpils
country: Latvia
facility: Investigational Site Number 428001
city: Liepaja
country: Latvia
facility: Investigational Site Number 428002
city: Riga
country: Latvia
facility: Investigational Site Number 428003
city: Riga
country: Latvia
facility: Investigational Site Number 428007
city: Riga
country: Latvia
facility: Investigational Site Number 428004
city: Sigulda
country: Latvia
facility: Investigational Site Number 428006
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440003
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440002
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440004
city: Klaipeda
country: Lithuania
facility: Investigational Site Number 440006
city: Panevezys
country: Lithuania
facility: Investigational Site Number 440005
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440001
city: Acapulco
country: Mexico
facility: Investigational Site Number 484011
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484008
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484033
city: Chihuahua
country: Mexico
facility: Investigational Site Number 484016
city: Ciudad Madero
country: Mexico
facility: Investigational Site Number 484023
city: Durango
country: Mexico
facility: Investigational Site Number 484007
city: Durango
country: Mexico
facility: Investigational Site Number 484001
city: Durango
country: Mexico
facility: Investigational Site Number 484041
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484032
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484034
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484014
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484028
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484021
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484006
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484018
city: Leon
country: Mexico
facility: Investigational Site Number 484024
city: Mexico City
country: Mexico
facility: Investigational Site Number 484026
city: Mexico City
country: Mexico
facility: Investigational Site Number 484022
city: Mexico City
country: Mexico
facility: Investigational Site Number 484013
city: Monterrey
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484025
city: Monterrey
country: Mexico
facility: Investigational Site Number 484002
city: Monterrey
country: Mexico
facility: Investigational Site Number 484005
city: Monterrey
country: Mexico
facility: Investigational Site Number 484004
city: Morelia
country: Mexico
facility: Investigational Site Number 484035
city: San Luis Potosi
country: Mexico
facility: Investigational Site Number 484020
city: Tlalnepantla
country: Mexico
facility: Investigational Site Number 484017
city: Xalapa
country: Mexico
facility: Investigational Site Number 484031
city: Alkmaar
country: Netherlands
facility: Investigational Site Number 528005
city: Den Haag
country: Netherlands
facility: Investigational Site Number 528007
city: Deventer
country: Netherlands
facility: Investigational Site Number 528008
city: Hoorn
country: Netherlands
facility: Investigational Site Number 528004
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528001
city: Tilburg
country: Netherlands
facility: Investigational Site Number 528003
city: Venlo
country: Netherlands
facility: Investigational Site Number 528006
city: Bodø
country: Norway
facility: Investigational Site Number 578003
city: Haugesund
country: Norway
facility: Investigational Site Number 578002
city: Stavanger
country: Norway
facility: Investigational Site Number 578001
city: Cuidad De Panama
country: Panama
facility: Investigational Site Number 591001
city: Cuidad De Panama
country: Panama
facility: Investigational Site Number 591003
city: La Chorrera
country: Panama
facility: Investigational Site Number 591004
city: Penonome
country: Panama
facility: Investigational Site Number 591002
city: Arequipa
country: Peru
facility: Investigational Site Number 604007
city: Callao
country: Peru
facility: Investigational Site Number 604014
city: Lima
country: Peru
facility: Investigational Site Number 604011
city: Lima
country: Peru
facility: Investigational Site Number 604019
city: Lima
country: Peru
facility: Investigational Site Number 604013
city: Lima
country: Peru
facility: Investigational Site Number 604010
city: Lima
country: Peru
facility: Investigational Site Number 604002
city: Lima
country: Peru
facility: Investigational Site Number 604006
city: Lima
country: Peru
facility: Investigational Site Number 604015
city: Lima
country: Peru
facility: Investigational Site Number 604016
city: Lima
country: Peru
facility: Investigational Site Number 604017
city: Lima
country: Peru
facility: Investigational Site Number 604018
city: Lima
country: Peru
facility: Investigational Site Number 604005
city: Lima
country: Peru
facility: Investigational Site Number 604009
city: Lima
country: Peru
facility: Investigational Site Number 604001
city: Cavite
country: Philippines
facility: Investigational Site Number 608006
city: Iligan City, Lanao Del Norte
country: Philippines
facility: Investigational Site Number 608009
city: Makati City
country: Philippines
facility: Investigational Site Number 608003
city: Manila
country: Philippines
facility: Investigational Site Number 608001
city: Manila
country: Philippines
facility: Investigational Site Number 608007
city: Marikina City
country: Philippines
facility: Investigational Site Number 608005
city: Pasay City
country: Philippines
facility: Investigational Site Number 608002
city: Quezon City
country: Philippines
facility: Investigational Site Number 608008
city: ?ód?
country: Poland
facility: Investigational Site Number 616005
city: Bialystok
country: Poland
facility: Investigational Site Number 616008
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616019
city: Czeladz
country: Poland
facility: Investigational Site Number 616012
city: Czestochowa
country: Poland
facility: Investigational Site Number 616007
city: Gdynia
country: Poland
facility: Investigational Site Number 616014
city: Gliwice
country: Poland
facility: Investigational Site Number 616013
city: Grodzisk Mazowiecki
country: Poland
facility: Investigational Site Number 616028
city: Katowice
country: Poland
facility: Investigational Site Number 616022
city: Krakow
country: Poland
facility: Investigational Site Number 616001
city: Krakow
country: Poland
facility: Investigational Site Number 616024
city: Leczyca
country: Poland
facility: Investigational Site Number 616029
city: Poland
country: Poland
facility: Investigational Site Number 616023
city: Pulawy
country: Poland
facility: Investigational Site Number 616021
city: Ruda Slaska
country: Poland
facility: Investigational Site Number 616006
city: Szczecin
country: Poland
facility: Investigational Site Number 616025
city: Warszawa
country: Poland
facility: Investigational Site Number 616032
city: Wroclaw
country: Poland
facility: Investigational Site Number 616020
city: Wroclaw
country: Poland
facility: Investigational Site Number 616011
city: Zgierz
country: Poland
facility: Investigational Site Number 616031
city: Amadora
country: Portugal
facility: Investigational Site Number 620005
city: Coimbra
country: Portugal
facility: Investigational Site Number 620003
city: Lisboa
country: Portugal
facility: Investigational Site Number 620001
city: Penafiel
country: Portugal
facility: Investigational Site Number 620007
city: Porto
country: Portugal
facility: Investigational Site Number 620006
city: Arad
country: Romania
facility: Investigational Site Number 642029
city: Baia Mare
country: Romania
facility: Investigational Site Number 642020
city: Braila
country: Romania
facility: Investigational Site Number 642019
city: Brasov
country: Romania
facility: Investigational Site Number 642003
city: Bucharest
country: Romania
facility: Investigational Site Number 642034
city: Bucuresti
country: Romania
facility: Investigational Site Number 642022
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
city: Bucuresti
country: Romania
facility: Investigational Site Number 642013
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642026
city: Craiova
country: Romania
facility: Investigational Site Number 642030
city: Craiova
country: Romania
facility: Investigational Site Number 642015
city: Deva
country: Romania
facility: Investigational Site Number 642007
city: Iasi
country: Romania
facility: Investigational Site Number 642011
city: Iasi
country: Romania
facility: Investigational Site Number 642010
city: Oradea
country: Romania
facility: Investigational Site Number 642016
city: Pitesti
country: Romania
facility: Investigational Site Number 642033
city: Ploiesti
country: Romania
facility: Investigational Site Number 642002
city: Suceava
country: Romania
facility: Investigational Site Number 642009
city: Targu Mures
country: Romania
facility: Investigational Site Number 642014
city: Targu Mures
country: Romania
facility: Investigational Site Number 642012
city: Timisoara
country: Romania
facility: Investigational Site Number 642018
city: Timisoara
country: Romania
facility: Investigational Site Number 642031
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 643023
city: Kazan
country: Russian Federation
facility: Investigational Site Number 643044
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643005
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643006
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 643061
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 643027
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643037
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643038
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643002
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643043
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643008
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643009
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643029
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643018
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643042
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643052
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643026
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643051
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643013
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643060
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643040
city: Nizhny Novgorod
country: Russian Federation
facility: Investigational Site Number 643034
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643054
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643055
city: Omsk
country: Russian Federation
facility: Investigational Site Number 643045
city: Penza
country: Russian Federation
facility: Investigational Site Number 643030
city: Perm
country: Russian Federation
facility: Investigational Site Number 643017
city: Perm
country: Russian Federation
facility: Investigational Site Number 643049
city: Rostov-Na-Donu
country: Russian Federation
facility: Investigational Site Number 643048
city: Ryazan
country: Russian Federation
facility: Investigational Site Number 643047
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643039
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643025
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643056
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643010
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643033
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643019
city: Smolensk
country: Russian Federation
facility: Investigational Site Number 643014
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643024
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643031
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643035
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643022
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643057
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643041
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643036
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643011
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643004
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 643028
city: Tver
country: Russian Federation
facility: Investigational Site Number 643016
city: Tyumen
country: Russian Federation
facility: Investigational Site Number 643012
city: Vladimir
country: Russian Federation
facility: Investigational Site Number 643059
city: Voronezh
country: Russian Federation
facility: Investigational Site Number 643058
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643020
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643062
city: Belgrade
country: Serbia
facility: Investigational Site Number 688002
city: Belgrade
country: Serbia
facility: Investigational Site Number 688003
city: Belgrade
country: Serbia
facility: Investigational Site Number 688004
city: Belgrade
country: Serbia
facility: Investigational Site Number 688006
city: Belgrade
country: Serbia
facility: Investigational Site Number 688008
city: Belgrade
country: Serbia
facility: Investigational Site Number 688009
city: Belgrade
country: Serbia
facility: Investigational Site Number 688010
city: Belgrade
country: Serbia
facility: Investigational Site Number 688001
city: Nis
country: Serbia
facility: Investigational Site Number 688005
city: Nis
country: Serbia
facility: Investigational Site Number 688007
city: Alberton
country: South Africa
facility: Investigational Site Number 710020
city: Cape Town
country: South Africa
facility: Investigational Site Number 710017
city: Cape Town
country: South Africa
facility: Investigational Site Number 710006
city: Cape Town
country: South Africa
facility: Investigational Site Number 710010
city: Cape Town
country: South Africa
facility: Investigational Site Number 710025
city: Chatsworth
country: South Africa
facility: Investigational Site Number 710008
city: Durban
country: South Africa
facility: Investigational Site Number 710011
city: George
country: South Africa
facility: Investigational Site Number 710015
city: Kempton Park
country: South Africa
facility: Investigational Site Number 710019
city: Paarl
country: South Africa
facility: Investigational Site Number 710014
city: Parow
country: South Africa
facility: Investigational Site Number 710023
city: Pretoria
country: South Africa
facility: Investigational Site Number 710002
city: Pretoria
country: South Africa
facility: Investigational Site Number 710001
city: Richards Bay
country: South Africa
facility: Investigational Site Number 710005
city: Somerset West
country: South Africa
facility: Investigational Site Number 710007
city: Worcester
country: South Africa
facility: Investigational Site Number 710004
city: Alcalá De Henares
country: Spain
facility: Investigational Site Number 724005
city: Almería
country: Spain
facility: Investigational Site Number 724016
city: Barakaldo
country: Spain
facility: Investigational Site Number 724012
city: Barcelona
country: Spain
facility: Investigational Site Number 724018
city: Bilbao
country: Spain
facility: Investigational Site Number 724014
city: Cáceres
country: Spain
facility: Investigational Site Number 724015
city: La Coruña
country: Spain
facility: Investigational Site Number 724013
city: Lérida
country: Spain
facility: Investigational Site Number 724008
city: Madrid
country: Spain
facility: Investigational Site Number 724011
city: Murcia
country: Spain
facility: Investigational Site Number 724017
city: Oviedo
country: Spain
facility: Investigational Site Number 724022
city: Pontevedra
country: Spain
facility: Investigational Site Number 724003
city: Sevilla
country: Spain
facility: Investigational Site Number 724001
city: Valencia
country: Spain
facility: Investigational Site Number 724020
city: Vigo
country: Spain
facility: Investigational Site Number 724004
city: Karlstad
country: Sweden
facility: Investigational Site Number 752012
city: Kristianstad
country: Sweden
facility: Investigational Site Number 752011
city: Ljungby
country: Sweden
facility: Investigational Site Number 752006
city: Oskarshamn
country: Sweden
facility: Investigational Site Number 752009
city: Stockholm
country: Sweden
facility: Investigational Site Number 752004
city: Stockholm
country: Sweden
facility: Investigational Site Number 752007
city: Växjö
country: Sweden
facility: Investigational Site Number 752002
city: Lugano
country: Switzerland
facility: Investigational Site Number 756003
city: Chia-Yi
country: Taiwan
facility: Investigational Site Number 158005
city: Taichung
country: Taiwan
facility: Investigational Site Number 158004
city: Tainan Hsien
country: Taiwan
facility: Investigational Site Number 158006
city: Taipei 111
country: Taiwan
facility: Investigational Site Number 158007
city: Taipei Hsien
country: Taiwan
facility: Investigational Site Number 158003
city: Taipei
country: Taiwan
facility: Investigational Site Number 158002
city: Taipei
country: Taiwan
facility: Investigational Site Number 158001
city: Taipei
country: Taiwan
facility: Investigational Site Number 158008
city: Sfax
country: Tunisia
facility: Investigational Site Number 788003
city: Tunis
country: Tunisia
facility: Investigational Site Number 788005
city: Tunis
country: Tunisia
facility: Investigational Site Number 788004
city: Tunis
country: Tunisia
facility: Investigational Site Number 788002
city: Tunis
country: Tunisia
facility: Investigational Site Number 788001
city: Ankara
country: Turkey
facility: Investigational Site Number 792004
city: Ankara
country: Turkey
facility: Investigational Site Number 792002
city: Ankara
country: Turkey
facility: Investigational Site Number 792012
city: Capa / Istanbul
country: Turkey
facility: Investigational Site Number 792001
city: Istanbul
country: Turkey
facility: Investigational Site Number 792015
city: Istanbul
country: Turkey
facility: Investigational Site Number 792008
city: Istanbul
country: Turkey
facility: Investigational Site Number 792014
city: Izmir
country: Turkey
facility: Investigational Site Number 792003
city: Izmir
country: Turkey
facility: Investigational Site Number 792007
city: Mersin
country: Turkey
facility: Investigational Site Number 792011
city: Samsun
country: Turkey
facility: Investigational Site Number 792013
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804004
city: Dnepropetrovsk
country: Ukraine
facility: Investigational Site Number 804006
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 804002
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804010
city: Kharkov
country: Ukraine
facility: Investigational Site Number 804009
city: Kiev
country: Ukraine
facility: Investigational Site Number 804003
city: Kiev
country: Ukraine
facility: Investigational Site Number 804011
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804012
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804013
city: Lviv
country: Ukraine
facility: Investigational Site Number 804005
city: Odessa
country: Ukraine
facility: Investigational Site Number 804007
city: Odessa
country: Ukraine
facility: Investigational Site Number 804008
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number 784001
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number 784002
city: Antrim
country: United Kingdom
facility: Investigational Site Number 826042
city: Ashton-Under-Lyne
country: United Kingdom
facility: Investigational Site Number 826002
city: Barnstaple
country: United Kingdom
facility: Investigational Site Number 826026
city: Bath
country: United Kingdom
facility: Investigational Site Number 826017
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826034
city: Bolton
country: United Kingdom
facility: Investigational Site Number 826052
city: Bradford
country: United Kingdom
facility: Investigational Site Number 826005
city: Carmarthen
country: United Kingdom
facility: Investigational Site Number 826048
city: Chester
country: United Kingdom
facility: Investigational Site Number 826037
city: Dumfries
country: United Kingdom
facility: Investigational Site Number 826011
city: East Kilbride
country: United Kingdom
facility: Investigational Site Number 826044
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number 826023
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 826008
city: Harrogate
country: United Kingdom
facility: Investigational Site Number 826010
city: Ipswich
country: United Kingdom
facility: Investigational Site Number 826040
city: Larbert
country: United Kingdom
facility: Investigational Site Number 826033
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826027
city: Londonderry
country: United Kingdom
facility: Investigational Site Number 826039
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826036
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826021
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826006
city: Norwich
country: United Kingdom
facility: Investigational Site Number 826049
city: Nuneaton
country: United Kingdom
facility: Investigational Site Number 826020
city: Oldham
country: United Kingdom
facility: Investigational Site Number 826009
city: Salford
country: United Kingdom
facility: Investigational Site Number 826007
city: Stoke-On-Trent
country: United Kingdom
facility: Investigational Site Number 826045
city: Swansea
country: United Kingdom
facility: Investigational Site Number 826038
city: Taunton
country: United Kingdom
facility: Investigational Site Number 826018
city: Truro
country: United Kingdom
facility: Investigational Site Number 826016
city: Wolverhampton
country: United Kingdom
facility: Investigational Site Number 826046
city: Yeovil
country: United Kingdom
facility: Investigational Site Number 826019
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Pfeffer 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.
citation: Gerstein 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.
citation: Wijkman 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.
citation: Shin 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.
citation: Seferovic 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.
citation: Muskiet 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.
citation: Wittbrodt 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.
citation: Wolsk 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.
citation: Wohlfart 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.