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NCT01147250 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
A Phase 3 study of Acute Coronary Syndrome, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 6,068
- Enrollment target
- 20
- Study locations
NCT01147250: Completed Phase 3 study of Acute Coronary Syndrome, sponsored by Sanofi.
NCT01147250 is a Phase 3 study of Acute Coronary Syndrome that has completed, run by Sanofi. The registered enrollment target is 6,068 participants, above the 2,570-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (136% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147250, a Phase 3 study of Acute Coronary Syndrome, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6,068 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lixisenatide (AVE0010)
Study Locations (20)
Alabama
- Investigational Site Number 840415 - Birmingham
- Investigational Site Number 840307 - Foley
- Investigational Site Number 840692 - Mobile
- Investigational Site Number 840037 - Mobile
- Investigational Site Number 840210 - Mobile
- Investigational Site Number 840326 - Muscle Shoals
- Investigational Site Number 840393 - Toney
Arizona
- Investigational Site Number 840656 - Mesa
- Investigational Site Number 840506 - Phoenix
- Investigational Site Number 840520 - Phoenix
- Investigational Site Number 840322 - Phoenix
- Investigational Site Number 840250 - Tempe
- Investigational Site Number 840042 - Tucson
Arkansas
- Investigational Site Number 840303 - Hot Springs
- Investigational Site Number 840184 - Jonesboro
- Investigational Site Number 840361 - Little Rock
- Investigational Site Number 840023 - Little Rock
California
- Investigational Site Number 840706 - Anaheim
- Investigational Site Number 840497 - Anaheim
- Investigational Site Number 840667 - Downey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,068 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT01147250 record still lists
NCT01147250 is an interventional study that assigns participants to a tested intervention. Its 6,068 participants enrollment target places it among the larger protocols in the corpus, above the 2,570-participant average among 40 other Acute Coronary Syndrome trials with a reported enrollment target (136% higher).
The record links to 1 condition, with Acute Coronary Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01147250 names 20 study sites across 4 states, led by Alabama, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01147250 about?
NCT01147250 is a clinical study titled "Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)". 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 recentl...
What is the current status of trial NCT01147250?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6,068 participants. The study started on 2010-06. Estimated completion is 2015-02.
What conditions does trial NCT01147250 study?
This clinical trial studies the following conditions: Acute Coronary Syndrome.
What interventions are being tested in trial NCT01147250?
The interventions under investigation include: Placebo (DRUG), Lixisenatide (AVE0010) (DRUG).
Who is sponsoring clinical trial NCT01147250?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01147250 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Coronary Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01147250's enrollment target sits among peer trials
6,068 6th of 40 higher than 35 of 40 other Acute Coronary Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Coronary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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