A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study is 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amarin Pharma Inc.
• Treatments: Eicosapentaenoic acid ethyl ester

Criteria

Inclusion Criteria:

• Men and non-pregnant or sterile women ages 45 and older

• Hypertriglyceridemia

• On statin therapy for at least four weeks

• Either having established Cardiovascular Disease or at high risk for Cardiovascular Disease

Exclusion Criteria:

• Severe heart failure

• Any life-threatening disease other than Cardiovascular Disease

• Active severe liver disease

• Hemoglobin A1c >10.0%

• Poorly controlled hypertension

• Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure

• Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)

• Known hypersensitivity to the study product, fish and/or shellfish, or placebo

• History of acute or chronic pancreatitis

• Patients are excluded if using the following medications:

• PCSK9 inhibitors

• niacin >200 mg/day or fibrates;

• any omega-3 fatty acid medications ;

• dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);

• bile acid sequestrants