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

NCT ID: NCT01147250

Last Updated: 2016-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6068 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-02-28

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo matched to lixisenatide once daily (QD) up to end of treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.

Lixisenatide

Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment.

Group Type: EXPERIMENTAL

Lixisenatide (AVE0010)

Intervention Type: DRUG

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.

Interventions

Lixisenatide (AVE0010)

Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.

Intervention Type: DRUG

Placebo

Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.

Intervention Type: DRUG

Other Intervention Names

Lyxumia

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840415

Birmingham, Alabama, United States

Investigational Site Number 840307

Foley, Alabama, United States

Investigational Site Number 840692

Mobile, Alabama, United States

Investigational Site Number 840037

Mobile, Alabama, United States

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Mobile, Alabama, United States

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Muscle Shoals, Alabama, United States

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Toney, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Downey, California, United States

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Fresno, California, United States

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Hawthorne, California, United States

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Inglewood, California, United States

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Inglewood, California, United States

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La Mesa, California, United States

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Loma Linda, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Merced, California, United States

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National City, California, United States

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Northridge, California, United States

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Oakland, California, United States

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Orange, California, United States

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Homosassa, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Oviedo, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Joliet, Illinois, United States

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Peoria, Illinois, United States

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Elwood, Indiana, United States

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Gary, Indiana, United States

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Hammond, Indiana, United States

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Huntington, Indiana, United States

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Indianapolis, Indiana, United States

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Topeka, Kansas, United States

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Covington, Kentucky, United States

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Madisonville, Kentucky, United States

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Owensboro, Kentucky, United States

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Pikeville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Hammond, Louisiana, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Annapolis, Maryland, United States

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Catonsville, Maryland, United States

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Rockville, Maryland, United States

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Takoma Park, Maryland, United States

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Towson, Maryland, United States

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Alpena, Michigan, United States

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Buckley, Michigan, United States

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Chesterfield, Michigan, United States

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Dearborn, Michigan, United States

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Detroit, Michigan, United States

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Kalamazoo, Michigan, United States

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Southfield, Michigan, United States

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Duluth, Minnesota, United States

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Eagan, Minnesota, United States

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Biloxi, Mississippi, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Linden, New Jersey, United States

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Ridgewood, New Jersey, United States

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Somerset, New Jersey, United States

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Albany, New York, United States

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Jamaica, New York, United States

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Mineola, New York, United States

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Northport, New York, United States

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Rosedale, New York, United States

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Asheville, North Carolina, United States

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Calabash, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Elizabeth City, North Carolina, United States

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Greensboro, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Monroe, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Marion, Ohio, United States

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Bend, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Butler, Pennsylvania, United States

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Clark Summit, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Anderson, South Carolina, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Greer, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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Taylors, South Carolina, United States

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Rapid City, South Dakota, United States

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Bartlett, Tennessee, United States

Investigational Site Number 840308

Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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El Paso, Texas, United States

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Fair Oaks Ranch, Texas, United States

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Houston, Texas, United States

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Longview, Texas, United States

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Lubbock, Texas, United States

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Lubbock, Texas, United States

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Marshall, Texas, United States

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Plano, Texas, United States

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Richmond, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Waco, Texas, United States

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American Fork, Utah, United States

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Draper, Utah, United States

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Charlottesville, Virginia, United States

Investigational Site Number 840180

Chesapeake, Virginia, United States

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Chesapeake, Virginia, United States

Investigational Site Number 840128

Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

Investigational Site Number 840001

Richmond, Virginia, United States

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Roanoke, Virginia, United States

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Olympia, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Fairmount, Wisconsin, United States

Investigational Site Number 840121

La Crosse, Wisconsin, United States

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Milwaukee, Wisconsin, United States

Investigational Site Number 032028

Adrogué, , Argentina

Investigational Site Number 032030

Bahía Blanca, , Argentina

Investigational Site Number 032043

Bahía Blanca, , Argentina

Investigational Site Number 032054

Bahía Blanca, , Argentina

Investigational Site Number 032066

Caba, , Argentina

Investigational Site Number 032049

Caba, , Argentina

Investigational Site Number 032056

Caba, , Argentina

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Caba, , Argentina

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Capital Federal, , Argentina

Investigational Site Number 032009

Capital Federal, , Argentina

Investigational Site Number 032050

Cipolletti, , Argentina

Investigational Site Number 032052

Ciudad Autonoma de Bs.As, , Argentina

Investigational Site Number 032020

Coronel Suárez, , Argentina

Investigational Site Number 032004

Corrientes, , Argentina

Investigational Site Number 032018

Corrientes, , Argentina

Investigational Site Number 032015

Córdoba, , Argentina

Investigational Site Number 032011

Córdoba, , Argentina

Investigational Site Number 032022

Córdoba, , Argentina

Investigational Site Number 032037

Córdoba, , Argentina

Investigational Site Number 032005

Godoy Cruz, , Argentina

Investigational Site Number 032042

Haedo, , Argentina

Investigational Site Number 032019

Junín, , Argentina

Investigational Site Number 032063

La Plata, , Argentina

Investigational Site Number 032040

Lanús, , Argentina

Investigational Site Number 032036

Mar del Plata, , Argentina

Investigational Site Number 032039

Mar del Plata, , Argentina

Investigational Site Number 032058

Mendoza, , Argentina

Investigational Site Number 032038

Morón, , Argentina

Investigational Site Number 032002

Paraná, , Argentina

Investigational Site Number 032023

Qilmes, , Argentina

Investigational Site Number 032047

Rafaela, , Argentina

Investigational Site Number 032024

Ramos Mejía, , Argentina

Investigational Site Number 032006

Resistencia, , Argentina

Investigational Site Number 032012

Rosario, , Argentina

Investigational Site Number 032027

Rosario, , Argentina

Investigational Site Number 032055

Salta, , Argentina

Investigational Site Number 032065

Salta, , Argentina

Investigational Site Number 032051

San Miguel de Tucumán, , Argentina

Investigational Site Number 032008

San Miguel de Tucumán, , Argentina

Investigational Site Number 032033

San Nicolás, , Argentina

Investigational Site Number 032045

Santa Fe, , Argentina

Investigational Site Number 032035

Santa Fe, , Argentina

Investigational Site Number 032062

Santa Rosa, , Argentina

Investigational Site Number 032034

Venado Tuerto, , Argentina

Investigational Site Number 032046

Villa María, , Argentina

Investigational Site Number 032029

Zárate, , Argentina

Investigational Site Number 036015

Epping, , Australia

Investigational Site Number 036001

Fremantle, , Australia

Investigational Site Number 036009

Geelong, , Australia

Investigational Site Number 036011

Perth, , Australia

Investigational Site Number 036005

St Leonards, , Australia

Investigational Site Number 036016

Townsville, , Australia

Investigational Site Number 040002

Graz, , Austria

Investigational Site Number 040001

Vienna, , Austria

Investigational Site Number 112002

Minsk, , Belarus

Investigational Site Number 112003

Minsk, , Belarus

Investigational Site Number 112001

Minsk, , Belarus

Investigational Site Number 056001

Brussels, , Belgium

Investigational Site Number 056003

Leuven, , Belgium

Investigational Site Number 076024

Belém, , Brazil

Investigational Site Number 076006

Belo Horizonte, , Brazil

Investigational Site Number 076012

Belo Horizonte, , Brazil

Investigational Site Number 076021

Brasília, , Brazil

Investigational Site Number 076002

Campinas, , Brazil

Investigational Site Number 076019

Curitiba, , Brazil

Investigational Site Number 076003

Fortaleza, , Brazil

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Fortaleza, , Brazil

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Fortaleza, , Brazil

Investigational Site Number 076023

Goiânia, , Brazil

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Marília, , Brazil

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Passo Fundo, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

Investigational Site Number 076026

Porto Alegre, , Brazil

Investigational Site Number 076025

Recife, , Brazil

Investigational Site Number 076020

Salvador, , Brazil

Investigational Site Number 076016

São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Uberlândia, , Brazil

Investigational Site Number 100002

Byala, , Bulgaria

Investigational Site Number 100011

Gabrovo, , Bulgaria

Investigational Site Number 100001

Kazanlak, , Bulgaria

Investigational Site Number 100006

Lovech, , Bulgaria

Investigational Site Number 100004

Pleven, , Bulgaria

Investigational Site Number 100003

Plovdiv, , Bulgaria

Investigational Site Number 100007

Plovdiv, , Bulgaria

Investigational Site Number 100016

Sandanski, , Bulgaria

Investigational Site Number 100010

Sofia, , Bulgaria

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Sofia, , Bulgaria

Investigational Site Number 100005

Varna, , Bulgaria

Investigational Site Number 124024

Calgary, , Canada

Investigational Site Number 124016

Cambridge, , Canada

Investigational Site Number 124026

Edmonton, , Canada

Investigational Site Number 124005

Greater Sudbury, , Canada

Investigational Site Number 124001

Laval, , Canada

Investigational Site Number 124021

Montreal, , Canada

Investigational Site Number 124006

Montreal, , Canada

Investigational Site Number 124027

Oshawa, , Canada

Investigational Site Number 124025

Québec, , Canada

Investigational Site Number 124028

Red Deer, , Canada

Investigational Site Number 124003

Saint-Marc-des-Carrieres, , Canada

Investigational Site Number 124007

Sarnia, , Canada

Investigational Site Number 124002

Thetford-Mines, , Canada

Investigational Site Number 152024

Antofagasta, , Chile

Investigational Site Number 152023

Concepción, , Chile

Investigational Site Number 152041

Osorno, , Chile

Investigational Site Number 152040

Port Montt, , Chile

Investigational Site Number 152038

Punta Arenas, , Chile

Investigational Site Number 152036

San Felipe, , Chile

Investigational Site Number 152035

Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Talca, , Chile

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Temuco, , Chile

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Temuco, , Chile

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Valdivia, , Chile

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Valparaíso, , Chile

Investigational Site Number 152010

Viña del Mar, , Chile

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Viña del Mar, , Chile

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Beijing, , China

Investigational Site Number 156034

Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Dalian, , China

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Guangzhou, , China

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Jinan, , China

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Jinan, , China

Investigational Site Number 156009

Nanjing, , China

Investigational Site Number 156013

Shanghai, , China

Investigational Site Number 156019

Shanghai, , China

Investigational Site Number 156032

Shenyang, , China

Investigational Site Number 156022

Shenyang, , China

Investigational Site Number 156004

Suzhou, , China

Investigational Site Number 156033

Ürümqi, , 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, , Denmark

Investigational Site Number 208009

Aarhus C, , Denmark

Investigational Site Number 208011

Esbjerg, , Denmark

Investigational Site Number 208004

Farsø, , Denmark

Investigational Site Number 208002

Hellerup, , Denmark

Investigational Site Number 208010

Herlev, , Denmark

Investigational Site Number 208008

Hillerød, , Denmark

Investigational Site Number 208006

Hvidovre, , Denmark

Investigational Site Number 208001

København NV, , Denmark

Investigational Site Number 208005

København S, , Denmark

Investigational Site Number 208007

København Ø, , Denmark

Investigational Site Number 218001

Guayaquil, , Ecuador

Investigational Site Number 218005

Guayaquil, , Ecuador

Investigational Site Number 218002

Quito, , Ecuador

Investigational Site Number 818002

Alexandria, , Egypt

Investigational Site Number 818001

Cairo, , Egypt

Investigational Site Number 233004

Tallinn, , Estonia

Investigational Site Number 233002

Tallinn, , Estonia

Investigational Site Number 233001

Tallinn, , Estonia

Investigational Site Number 233003

Tallinn, , Estonia

Investigational Site Number 233005

Tartu, , Estonia

Investigational Site Number 233006

Viljandimaa, , Estonia

Investigational Site Number 246005

Jyväskylä, , Finland

Investigational Site Number 246003

Rauma, , Finland

Investigational Site Number 246010

Tampere, , Finland

Investigational Site Number 246009

Turku, , Finland

Investigational Site Number 246007

Valkeakoski, , Finland

Investigational Site Number 246012

Vantaa, , Finland

Investigational Site Number 250008

Brest, , France

Investigational Site Number 250002

Corbeil-Essonnes, , France

Investigational Site Number 250005

Nantes, , France

Investigational Site Number 250014

Nîmes, , France

Investigational Site Number 250007

Paris, , France

Investigational Site Number 250011

Pessac, , France

Investigational Site Number 250012

Poitiers, , France

Investigational Site Number 250006

Rennes, , France

Investigational Site Number 250001

Toulouse, , 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, , Germany

Investigational Site Number 276022

Bochum, , Germany

Investigational Site Number 276005

Chemnitz, , Germany

Investigational Site Number 276021

Dresden, , Germany

Investigational Site Number 276024

Dresden, , Germany

Investigational Site Number 276007

Elsterwerda, , Germany

Investigational Site Number 276018

Frankfurt A.M., , Germany

Investigational Site Number 276011

Frankfurt am Main, , Germany

Investigational Site Number 276017

Görlitz, , Germany

Investigational Site Number 276025

Haßloch, , Germany

Investigational Site Number 276009

Heidelberg, , Germany

Investigational Site Number 276019

Leipzig, , Germany

Investigational Site Number 276020

Magdeburg, , Germany

Investigational Site Number 276028

Mühldorf, , Germany

Investigational Site Number 276014

Pirna, , Germany

Investigational Site Number 276016

Pohlheim, , Germany

Investigational Site Number 276026

Rotenburg an der Fulda, , Germany

Investigational Site Number 320004

Guatemala City, , Guatemala

Investigational Site Number 320006

Guatemala City, , Guatemala

Investigational Site Number 320012

Guatemala City, , Guatemala

Investigational Site Number 320014

Guatemala City, , Guatemala

Investigational Site Number 320001

Guatemala City, , Guatemala

Investigational Site Number 320002

Guatemala City, , Guatemala

Investigational Site Number 320007

Guatemala City, , Guatemala

Investigational Site Number 320008

Guatemala City, , Guatemala

Investigational Site Number 320011

Guatemala City, , Guatemala

Investigational Site Number 320015

Quetzaltenango, , Guatemala

Investigational Site Number 356019

Ahmedabad, , India

Investigational Site Number 356002

Bangalore, , India

Investigational Site Number 356010

Bangalore, , India

Investigational Site Number 356026

Bangalore, , India

Investigational Site Number 356024

Belagavi, , India

Investigational Site Number 356012

Chandigarh, , India

Investigational Site Number 356022

Gurgaon, , India

Investigational Site Number 356029

Hubli, , India

Investigational Site Number 356020

Hyderabad, , India

Investigational Site Number 356031

Jaipur, , India

Investigational Site Number 356016

Kochi, , India

Investigational Site Number 356004

Kolkata, , India

Investigational Site Number 356015

Lucknow, , India

Investigational Site Number 356014

Lucknow, , India

Investigational Site Number 356009

Ludhiana, , India

Investigational Site Number 356025

Madurai, , India

Investigational Site Number 356032

Mangalore, , India

Investigational Site Number 356018

Manipal, , India

Investigational Site Number 356023

Mysore, , India

Investigational Site Number 356027

Nagpur, , India

Investigational Site Number 356006

Nagpur, , India

Investigational Site Number 356030

Nashik, , India

Investigational Site Number 356034

Nashik, , India

Investigational Site Number 356013

New Delhi, , India

Investigational Site Number 356017

New Delhi, , India

Investigational Site Number 356021

Pune, , India

Investigational Site Number 356028

Pune, , India

Investigational Site Number 376010

Afula, , Israel

Investigational Site Number 376006

Giv‘atayim, , Israel

Investigational Site Number 376002

Haifa, , Israel

Investigational Site Number 376008

Haifa, , Israel

Investigational Site Number 376001

Holon, , Israel

Investigational Site Number 376012

Jerusalem, , Israel

Investigational Site Number 376011

Nahariya, , Israel

Investigational Site Number 376005

Safed, , Israel

Investigational Site Number 376004

Tel Aviv, , Israel

Investigational Site Number 376003

Tel Litwinsky, , Israel

Investigational Site Number 376009

Tzrifin, , Israel

Investigational Site Number 380024

Carpi, , Italy

Investigational Site Number 380004

Chieri, , Italy

Investigational Site Number 380002

Chieti, , Italy

Investigational Site Number 380006

Fermo, , Italy

Investigational Site Number 380010

Florence, , Italy

Investigational Site Number 380009

Genova, , Italy

Investigational Site Number 380016

Messina, , Italy

Investigational Site Number 380023

Milan, , Italy

Investigational Site Number 380011

Milan, , Italy

Investigational Site Number 380012

Milan, , Italy

Investigational Site Number 380014

Napoli, , Italy

Investigational Site Number 380019

Novara, , Italy

Investigational Site Number 380005

Palermo, , Italy

Investigational Site Number 380001

Pisa, , Italy

Investigational Site Number 380013

Roma, , Italy

Investigational Site Number 380020

Rozzano, , 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, , Latvia

Investigational Site Number 428001

Daugavpils, , Latvia

Investigational Site Number 428002

Liepāja, , Latvia

Investigational Site Number 428003

Riga, , Latvia

Investigational Site Number 428007

Riga, , Latvia

Investigational Site Number 428004

Riga, , Latvia

Investigational Site Number 428006

Sigulda, , Latvia

Investigational Site Number 440003

Kaunas, , Lithuania

Investigational Site Number 440002

Kaunas, , Lithuania

Investigational Site Number 440004

Klaipėda, , Lithuania

Investigational Site Number 440006

Klaipėda, , Lithuania

Investigational Site Number 440005

Panevezys, , Lithuania

Investigational Site Number 440001

Vilnius, , Lithuania

Investigational Site Number 484011

Acapulco, , Mexico

Investigational Site Number 484008

Aguascalientes, , Mexico

Investigational Site Number 484033

Aguascalientes, , Mexico

Investigational Site Number 484016

Chihuahua City, , Mexico

Investigational Site Number 484023

Ciudad Madero, , Mexico

Investigational Site Number 484007

Durango, , Mexico

Investigational Site Number 484001

Durango, , Mexico

Investigational Site Number 484041

Durango, , Mexico

Investigational Site Number 484032

Guadalajara, , Mexico

Investigational Site Number 484034

Guadalajara, , Mexico

Investigational Site Number 484014

Guadalajara, , Mexico

Investigational Site Number 484028

Guadalajara, , Mexico

Investigational Site Number 484021

Guadalajara, , Mexico

Investigational Site Number 484006

Guadalajara, , Mexico

Investigational Site Number 484018

Guadalajara, , Mexico

Investigational Site Number 484024

León, , Mexico

Investigational Site Number 484026

Mexico City, , Mexico

Investigational Site Number 484022

Mexico City, , Mexico

Investigational Site Number 484013

Mexico City, , Mexico

Investigational Site Number 484003

Monterrey, , Mexico

Investigational Site Number 484025

Monterrey, , Mexico

Investigational Site Number 484002

Monterrey, , Mexico

Investigational Site Number 484005

Monterrey, , Mexico

Investigational Site Number 484004

Monterrey, , Mexico

Investigational Site Number 484035

Morelia, , Mexico

Investigational Site Number 484020

San Luis Potosí City, , Mexico

Investigational Site Number 484017

Tlalnepantla, , Mexico

Investigational Site Number 484031

Xalapa, , Mexico

Investigational Site Number 528005

Alkmaar, , Netherlands

Investigational Site Number 528008

Deventer, , Netherlands

Investigational Site Number 528004

Hoorn, , Netherlands

Investigational Site Number 528001

Rotterdam, , Netherlands

Investigational Site Number 528007

The Hague, , Netherlands

Investigational Site Number 528003

Tilburg, , Netherlands

Investigational Site Number 528006

Venlo, , Netherlands

Investigational Site Number 578003

Bodø, , Norway

Investigational Site Number 578002

Haugesund, , Norway

Investigational Site Number 578001

Stavanger, , 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, , Peru

Investigational Site Number 604014

Callao, , Peru

Investigational Site Number 604011

Lima, , Peru

Investigational Site Number 604019

Lima, , Peru

Investigational Site Number 604013

Lima, , Peru

Investigational Site Number 604010

Lima, , Peru

Investigational Site Number 604002

Lima, , Peru

Investigational Site Number 604006

Lima, , Peru

Investigational Site Number 604015

Lima, , Peru

Investigational Site Number 604016

Lima, , Peru

Investigational Site Number 604017

Lima, , Peru

Investigational Site Number 604018

Lima, , Peru

Investigational Site Number 604005

Lima, , Peru

Investigational Site Number 604009

Lima, , Peru

Investigational Site Number 604001

Lima, , Peru

Investigational Site Number 608006

Cavite, , Philippines

Investigational Site Number 608009

Iligan City, Lanao Del Norte, , Philippines

Investigational Site Number 608003

Makati City, , Philippines

Investigational Site Number 608001

Manila, , Philippines

Investigational Site Number 608007

Manila, , Philippines

Investigational Site Number 608005

Marikina City, , Philippines

Investigational Site Number 608002

Pasay, , Philippines

Investigational Site Number 608008

Quezon City, , Philippines

Investigational Site Number 616005

?ód?, , Poland

Investigational Site Number 616008

Bialystok, , Poland

Investigational Site Number 616019

Bydgoszcz, , Poland

Investigational Site Number 616012

Czeladź, , Poland

Investigational Site Number 616007

Częstochowa, , Poland

Investigational Site Number 616014

Gdynia, , Poland

Investigational Site Number 616013

Gliwice, , Poland

Investigational Site Number 616028

Grodzisk Mazowiecki, , Poland

Investigational Site Number 616022

Katowice, , Poland

Investigational Site Number 616001

Krakow, , Poland

Investigational Site Number 616024

Krakow, , Poland

Investigational Site Number 616023

Poland, , Poland

Investigational Site Number 616021

Puławy, , Poland

Investigational Site Number 616006

Ruda Śląska, , Poland

Investigational Site Number 616025

Szczecin, , Poland

Investigational Site Number 616032

Warsaw, , Poland

Investigational Site Number 616020

Wroclaw, , Poland

Investigational Site Number 616011

Wroclaw, , Poland

Investigational Site Number 616031

Zgierz, , Poland

Investigational Site Number 616029

Łęczyca, , Poland

Investigational Site Number 620005

Amadora, , Portugal

Investigational Site Number 620003

Coimbra, , Portugal

Investigational Site Number 620001

Lisbon, , Portugal

Investigational Site Number 620007

Penafiel, , Portugal

Investigational Site Number 620006

Porto, , Portugal

Investigational Site Number 642029

Arad, , Romania

Investigational Site Number 642020

Baia Mare, , Romania

Investigational Site Number 642003

Brasov, , Romania

Investigational Site Number 642019

Brăila, , Romania

Investigational Site Number 642034

Bucharest, , Romania

Investigational Site Number 642022

Bucharest, , Romania

Investigational Site Number 642001

Bucharest, , Romania

Investigational Site Number 642013

Bucharest, , Romania

Investigational Site Number 642026

Cluj-Napoca, , Romania

Investigational Site Number 642030

Craiova, , Romania

Investigational Site Number 642015

Craiova, , Romania

Investigational Site Number 642007

Deva, , Romania

Investigational Site Number 642011

Iași, , Romania

Investigational Site Number 642010

Iași, , Romania

Investigational Site Number 642016

Oradea, , Romania

Investigational Site Number 642033

Piteşti, , Romania

Investigational Site Number 642002

Ploieşti, , Romania

Investigational Site Number 642009

Suceava, , Romania

Investigational Site Number 642014

Târgu Mureş, , Romania

Investigational Site Number 642012

Târgu Mureş, , Romania

Investigational Site Number 642018

Timișoara, , Romania

Investigational Site Number 642031

Timișoara, , Romania

Investigational Site Number 643023

Barnaul, , Russia

Investigational Site Number 643044

Kazan', , Russia

Investigational Site Number 643005

Kemerovo, , Russia

Investigational Site Number 643006

Kemerovo, , Russia

Investigational Site Number 643061

Krasnodar, , Russia

Investigational Site Number 643027

Krasnodar, , Russia

Investigational Site Number 643037

Moscow, , Russia

Investigational Site Number 643038

Moscow, , Russia

Investigational Site Number 643002

Moscow, , Russia

Investigational Site Number 643043

Moscow, , Russia

Investigational Site Number 643008

Moscow, , Russia

Investigational Site Number 643009

Moscow, , Russia

Investigational Site Number 643029

Moscow, , Russia

Investigational Site Number 643018

Moscow, , Russia

Investigational Site Number 643042

Moscow, , Russia

Investigational Site Number 643052

Moscow, , Russia

Investigational Site Number 643026

Moscow, , Russia

Investigational Site Number 643003

Moscow, , Russia

Investigational Site Number 643051

Moscow, , Russia

Investigational Site Number 643013

Moscow, , Russia

Investigational Site Number 643001

Moscow, , Russia

Investigational Site Number 643060

Moscow, , Russia

Investigational Site Number 643040

Moscow, , Russia

Investigational Site Number 643034

Nizhny Novgorod, , Russia

Investigational Site Number 643054

Novosibirsk, , Russia

Investigational Site Number 643055

Novosibirsk, , Russia

Investigational Site Number 643045

Omsk, , Russia

Investigational Site Number 643030

Penza, , Russia

Investigational Site Number 643017

Perm, , Russia

Investigational Site Number 643049

Perm, , Russia

Investigational Site Number 643048

Rostov-on-Don, , Russia

Investigational Site Number 643047

Ryazan, , Russia

Investigational Site Number 643024

Saint Petersburg, , Russia

Investigational Site Number 643031

Saint Petersburg, , Russia

Investigational Site Number 643035

Saint Petersburg, , Russia

Investigational Site Number 643022

Saint Petersburg, , Russia

Investigational Site Number 643039

Saint Petersburg, , Russia

Investigational Site Number 643057

Saint Petersburg, , Russia

Investigational Site Number 643041

Saint Petersburg, , Russia

Investigational Site Number 643036

Saint Petersburg, , Russia

Investigational Site Number 643011

Saint Petersburg, , Russia

Investigational Site Number 643004

Saint Petersburg, , Russia

Investigational Site Number 643025

Saratov, , Russia

Investigational Site Number 643056

Saratov, , Russia

Investigational Site Number 643010

Saratov, , Russia

Investigational Site Number 643033

Saratov, , Russia

Investigational Site Number 643019

Saratov, , Russia

Investigational Site Number 643014

Smolensk, , Russia

Investigational Site Number 643028

Tomsk, , Russia

Investigational Site Number 643016

Tver', , Russia

Investigational Site Number 643012

Tyumen, , Russia

Investigational Site Number 643059

Vladimir, , Russia

Investigational Site Number 643058

Voronezh, , Russia

Investigational Site Number 643020

Yaroslavl, , Russia

Investigational Site Number 643062

Yaroslavl, , Russia

Investigational Site Number 688002

Belgrade, , Serbia

Investigational Site Number 688003

Belgrade, , Serbia

Investigational Site Number 688004

Belgrade, , Serbia

Investigational Site Number 688006

Belgrade, , Serbia

Investigational Site Number 688008

Belgrade, , Serbia

Investigational Site Number 688009

Belgrade, , Serbia

Investigational Site Number 688010

Belgrade, , Serbia

Investigational Site Number 688001

Belgrade, , Serbia

Investigational Site Number 688005

Niš, , Serbia

Investigational Site Number 688007

Niš, , Serbia

Investigational Site Number 710020

Alberton, , South Africa

Investigational Site Number 710017

Cape Town, , South Africa

Investigational Site Number 710006

Cape Town, , South Africa

Investigational Site Number 710010

Cape Town, , South Africa

Investigational Site Number 710025

Cape Town, , South Africa

Investigational Site Number 710008

Chatsworth, , South Africa

Investigational Site Number 710011

Durban, , South Africa

Investigational Site Number 710015

George, , South Africa

Investigational Site Number 710019

Kempton Park, , South Africa

Investigational Site Number 710014

Paarl, , South Africa

Investigational Site Number 710023

Parow, , South Africa

Investigational Site Number 710002

Pretoria, , South Africa

Investigational Site Number 710001

Pretoria, , South Africa

Investigational Site Number 710005

Richards Bay, , South Africa

Investigational Site Number 710007

Somerset West, , South Africa

Investigational Site Number 710004

Worcester, , South Africa

Investigational Site Number 410012

Bucheon-si, , South Korea

Investigational Site Number 410006

Daegu, , South Korea

Investigational Site Number 410009

Gwangju, , South Korea

Investigational Site Number 410008

Incheon, , South Korea

Investigational Site Number 410001

Incheon, , South Korea

Investigational Site Number 410004

Seongnam, , South Korea

Investigational Site Number 410014

Seoul, , South Korea

Investigational Site Number 410013

Seoul, , South Korea

Investigational Site Number 410002

Seoul, , South Korea

Investigational Site Number 410011

Seoul, , South Korea

Investigational Site Number 410010

Seoul, , South Korea

Investigational Site Number 410007

Wŏnju, , South Korea

Investigational Site Number 724013

A Coruña, , Spain

Investigational Site Number 724005

Alcalá de Henares, , Spain

Investigational Site Number 724016

Almería, , Spain

Investigational Site Number 724012

Barakaldo, , Spain

Investigational Site Number 724018

Barcelona, , Spain

Investigational Site Number 724014

Bilbao, , Spain

Investigational Site Number 724015

Cáceres, , Spain

Investigational Site Number 724008

Lleida, , Spain

Investigational Site Number 724011

Madrid, , Spain

Investigational Site Number 724017

Murcia, , Spain

Investigational Site Number 724022

Oviedo, , Spain

Investigational Site Number 724003

Pontevedra, , Spain

Investigational Site Number 724001

Seville, , Spain

Investigational Site Number 724020

Valencia, , Spain

Investigational Site Number 724004

Vigo, , Spain

Investigational Site Number 752012

Karlstad, , Sweden

Investigational Site Number 752011

Kristianstad, , Sweden

Investigational Site Number 752006

Ljungby, , Sweden

Investigational Site Number 752009

Oskarshamn, , Sweden

Investigational Site Number 752004

Stockholm, , Sweden

Investigational Site Number 752007

Stockholm, , Sweden

Investigational Site Number 752002

Vaxjo, , Sweden

Investigational Site Number 756003

Lugano, , Switzerland

Investigational Site Number 158005

Chiayi City, , Taiwan

Investigational Site Number 158004

Taichung, , Taiwan

Investigational Site Number 158006

Tainan Hsien, , Taiwan

Investigational Site Number 158002

Taipei, , Taiwan

Investigational Site Number 158007

Taipei, , Taiwan

Investigational Site Number 158001

Taipei, , Taiwan

Investigational Site Number 158008

Taipei, , Taiwan

Investigational Site Number 158003

Taipei Hsien, , Taiwan

Investigational Site Number 788003

Sfax, , Tunisia

Investigational Site Number 788005

Tunis, , Tunisia

Investigational Site Number 788004

Tunis, , Tunisia

Investigational Site Number 788002

Tunis, , Tunisia

Investigational Site Number 788001

Tunis, , Tunisia

Investigational Site Number 792004

Ankara, , Turkey (Türkiye)

Investigational Site Number 792002

Ankara, , Turkey (Türkiye)

Investigational Site Number 792012

Ankara, , Turkey (Türkiye)

Investigational Site Number 792001

Capa / Istanbul, , Turkey (Türkiye)

Investigational Site Number 792015

Istanbul, , Turkey (Türkiye)

Investigational Site Number 792008

Istanbul, , Turkey (Türkiye)

Investigational Site Number 792014

Istanbul, , Turkey (Türkiye)

Investigational Site Number 792003

Izmir, , Turkey (Türkiye)

Investigational Site Number 792007

Izmir, , Turkey (Türkiye)

Investigational Site Number 792011

Mersin, , Turkey (Türkiye)

Investigational Site Number 792013

Samsun, , Turkey (Türkiye)

Investigational Site Number 804004

Chernivtsi, , Ukraine

Investigational Site Number 804006

Dnipro, , Ukraine

Investigational Site Number 804002

Dnipropetrovsk, , Ukraine

Investigational Site Number 804009

Kharkiv, , Ukraine

Investigational Site Number 804010

Kharkiv, , Ukraine

Investigational Site Number 804003

Kiev, , Ukraine

Investigational Site Number 804011

Kiev, , Ukraine

Investigational Site Number 804012

Kyiv, , Ukraine

Investigational Site Number 804013

Kyiv, , Ukraine

Investigational Site Number 804005

Lviv, , Ukraine

Investigational Site Number 804007

Odesa, , Ukraine

Investigational Site Number 804008

Odesa, , Ukraine

Investigational Site Number 784001

Abu Dhabi, , United Arab Emirates

Investigational Site Number 784002

Dubai, , United Arab Emirates

Investigational Site Number 826042

Antrim, , United Kingdom

Investigational Site Number 826002

Ashton-under-Lyne, , United Kingdom

Investigational Site Number 826026

Barnstaple, , United Kingdom

Investigational Site Number 826017

Bath, , United Kingdom

Investigational Site Number 826034

Birmingham, , United Kingdom

Investigational Site Number 826052

Bolton, , United Kingdom

Investigational Site Number 826005

Bradford, , United Kingdom

Investigational Site Number 826048

Carmarthen, , United Kingdom

Investigational Site Number 826037

Chester, , United Kingdom

Investigational Site Number 826011

Dumfries, , United Kingdom

Investigational Site Number 826044

East Kilbride, , United Kingdom

Investigational Site Number 826023

Edinburgh, , United Kingdom

Investigational Site Number 826008

Glasgow, , United Kingdom

Investigational Site Number 826010

Harrogate, , United Kingdom

Investigational Site Number 826040

Ipswich, , United Kingdom

Investigational Site Number 826033

Larbert, , United Kingdom

Investigational Site Number 826027

Liverpool, , United Kingdom

Investigational Site Number 826039

Londonderry, , United Kingdom

Investigational Site Number 826036

Manchester, , United Kingdom

Investigational Site Number 826021

Manchester, , United Kingdom

Investigational Site Number 826006

Manchester, , United Kingdom

Investigational Site Number 826049

Norwich, , United Kingdom

Investigational Site Number 826020

Nuneaton, , United Kingdom

Investigational Site Number 826009

Oldham, , United Kingdom

Investigational Site Number 826007

Salford, , United Kingdom

Investigational Site Number 826045

Stoke-on-Trent, , United Kingdom

Investigational Site Number 826038

Swansea, , United Kingdom

Investigational Site Number 826018

Taunton, , United Kingdom

Investigational Site Number 826016

Truro, , United Kingdom

Investigational Site Number 826046

Wolverhampton, , United Kingdom

Investigational Site Number 826019

Yeovil, , United Kingdom

Countries

Puerto Rico; United States; Argentina; Australia; Austria; Belarus; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Denmark; Ecuador; Egypt; Estonia; Finland; France; Georgia; Germany; Guatemala; India; Israel; Italy; Japan; Latvia; Lithuania; Mexico; Netherlands; Norway; Panama; Peru; Philippines; Poland; Portugal; Romania; Russia; Serbia; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Tunisia; Turkey (Türkiye); Ukraine; United Arab Emirates; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 25965710 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26630143 (View on PubMed)

Natale 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.

Reference Type: DERIVED

PMID: 39963952 (View on PubMed)

Gerstein 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.

Reference Type: DERIVED

PMID: 36546588 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35817031 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33046070 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32212368 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30648112 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30292589 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29693361 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28554908 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23537041 (View on PubMed)

Other Identifiers

2009-012852-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1116-5558

Identifier Type: OTHER

Identifier Source: secondary_id

EFC11319

Identifier Type: -

Identifier Source: org_study_id