At a glance
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Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)
In Brief
A Phase 3 clinical trial evaluating AMR101, Placebo, and 1 other intervention for Cardiovascular Diseases. Completed, enrolled 8,179 participants across 410 sites in 11 countries.
Detailed Summary
AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.
Study Details
Timeline
Interventions
Parallel Assignment
Parallel Assignment
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)