Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 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 ≥500 mg/dL and ≤2000 mg/dL

• 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 pancreatitis

• 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.