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NCT01663402 · ClinicalTrials.gov registry record · Phase 3
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 18,924
- Enrollment target
NCT01663402: Completed Phase 3 study, sponsored by Sanofi.
NCT01663402 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 18,924 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2354% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663402, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18,924 participants
- Enrollment target
Study Summary
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: * To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). * To evaluate the safety and tolerability of alirocumab. * To evaluate the effect of alirocumab on lipid parameters.
Primary Outcome
All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observ
Interventions
- DRUG Placebo
- DRUG Alirocumab
- DRUG LMT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18,924 participants |
| Start Date | 2012-10 |
| Est. Completion | 2018-01-23 |
| Phase | Phase 3 |
What the finished NCT01663402 record still lists
NCT01663402 is an interventional study that assigns participants to a tested intervention. Its 18,924 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2354% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01663402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663402 about?
NCT01663402 is a clinical study titled "ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab". Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) i...
What is the current status of trial NCT01663402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18,924 participants. The study started on 2012-10. Estimated completion is 2018-01-23.
What interventions are being tested in trial NCT01663402?
The interventions under investigation include: Placebo (DRUG), Alirocumab (DRUG), LMT (DRUG).
Who is sponsoring clinical trial NCT01663402?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01663402's enrollment target sits among peer trials
18,924 11th of 2000 higher than 1,990 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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