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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 18,924 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01663402
The ClinicalTrials.gov registry entry for NCT01663402 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 18,924 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01663402 reports 0 study locations.
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.
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