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

Amarin

Status and phase

Completed

Phase 3

Conditions

Hypertriglyceridemia

Treatments

Drug: AMR101 (ethyl icosapentate) - 4 g/day

Drug: Placebo

Drug: AMR101 (ethyl icosapentate) - 2 g/day

Study type

Interventional

Funder types

Industry

Identifiers

NCT01047683

The MARINE Study (Other Identifier)

AMR-01-01-0016

Details and patient eligibility

About

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.

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.