NCT01492361

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,179 (actual)
• Sponsor: Amarin Pharma Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	AMR101	Parallel Assignment
DRUG	Placebo	Parallel Assignment
DRUG	Statin therapy	Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2011-12-15
• Last updated: 2022-04-14
• Results posted: 2022-04-14

Locations

410 sites across 11 countries: United States, Australia, Canada, India, Netherlands, New Zealand, Poland, Romania, Russia, South Africa, Ukraine