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

Amarin

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Drug: Statin therapy; Drug: Placebo; Drug: AMR101

Study type: Interventional

Funder types: Industry

Identifiers

NCT01492361

AMR-01-01-0019

Details and patient eligibility

About

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.

Enrollment: 8,179 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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8,179 participants in 2 patient groups, including a placebo group

AMR101

Experimental group

Description:

AMR101 (icosapent ethyl) + statin therapy, daily

Treatment:

Drug: AMR101

Drug: Statin therapy

Placebo

Placebo Comparator group

Description:

Placebo + statin therapy, daily

Treatment:

Drug: Placebo

Drug: Statin therapy