drugset / Trial / NCT01663402

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

NCT01663402 ↗

Phase 3 Completed 18924 enrolled Sanofi Regeneron Pharmaceuticals · collab
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2012-10
Primary completion
2018-01-23
Completion
2018-01-23

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Alirocumab 75 mg Q2W/Up to 150 mg Q2W; p = 0.0003; Hazard Ratio (HR) 0.85 reads as unknown NCT01663402 ↗

release “ODYSSEY OUTCOMES trial met its primary endpoint” reads as met primary endpoint regeneron.com ↗

release “the ODYSSEY OUTCOMES trial met its primary endpoint” reads as met primary endpoint regeneron.com ↗

release “ODYSSEY OUTCOMES trial. The trial met its primary endpoint, showing that Praluent® (alirocumab) Injection significantly reduced the risk of major adverse cardiovascular events (MACE)” reads as met primary endpoint regeneron.com ↗

release “In the large, prospective ODYSSEY OUTCOMES clinical trial, Praluent reduced the risk of major cardiovascular events” reads as met primary endpoint regeneron.com ↗

release “The trial met its primary endpoint, showing that Praluent significantly reduced the relative risk of major adverse CV events (MACE) by 15%” reads as met primary endpoint regeneron.com ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Alirocumab Monoclonal antibody 75 mg Subcutaneous
Subject Alirocumab Monoclonal antibody 150 mg Subcutaneous
Background Atorvastatin Small molecule — —
Background Rosuvastatin Small molecule — —