Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering high fasting triglyceride levels in patients with high risk for cardiovascular disease and fasting triglyceride levels ≥ 200 and < 500 mg/dL.

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

Details

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

Criteria

Inclusion Criteria:

• Men and women, ages >18

• Fasting triglyceride ≥200 mg/dL and <500 mg/dL

• LDL-C (low density lipoprotein - cholesterol) ≥40 mg/dL and <100mg/dL

• High risk for Coronary heart disease

• On stable dose of statin (atorvastatin, rosuvastatin or simvastatin)

• Provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

• Women who are pregnant or lactating, or planning to become pregnant

• Use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects

• History of bariatric surgery or currently on weight loss drugs

• Uncontrolled hypertension (BP > 160/100)

• HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or isotretinoin

• Consumption of more than 2 alcoholic beverages per day

• History of cancers (except if been disease free for >5 years OR history was basal or squamous cell skin cancer)

• Participation in another clinical trial involving an investigational agent in the last 30 days

• Other parameters will be assessed at the study center to ensure eligibility for this study.