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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT01492361

Run by

Amarin Pharma Inc.

People needed

8179

Starts

2011-11-01

Expected to finish

2018-05-01

Last updated by the study team

2022-04-14

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Amarin Investigational Site — Birmingham, Alabama, United States
• Amarin Investigational Site — Huntsville, Alabama, United States
• Amarin Investigational Site — Mobile, Alabama, United States
• Amarin Investigational Site — Muscle Shoals, Alabama, United States
• Amarin Investigational Site — Mesa, Arizona, United States
• Amarin Investigational Site — Phoenix, Arizona, United States
• Amarin Investigational Site — Tucson, Arizona, United States
• Amarin Investigational Site — Little Rock, Arkansas, United States
• Amarin Investigational Site — Beverly Hills, California, United States
• Amarin Investigational Site — Chino, California, United States
• Amarin Investigational Site — Concord, California, United States
• Amarin Investigational Site — El Cajon, California, United States
• Amarin Investigational Site — Encino, California, United States
• Amarin Investigational Site — Fair Oaks, California, United States
• Amarin Investigational Site — Hawaiian Gardens, California, United States
• Amarin Investigational Site — Lancaster, California, United States
• Amarin Investigational Site — Lincoln, California, United States
• Amarin Investigational Site — Los Angeles, California, United States
• Amarin Investigational Site — Los Angeles, California, United States
• Amarin Investigational Site — Los Angeles, California, United States
• Amarin Investigational Site — National City, California, United States
• Amarin Investigational Site — Orange, California, United States
• Amarin Investigational Site — Paramount, California, United States
• Amarin Investigational Site — Roseville, California, United States
• Amarin Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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