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

Amarin Pharma Inc.702 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

702

Conditions

Hypertriglyceridemia

Interventions

AMR101 (ethyl icosapentate) - 4 g/dayDRUG

AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks

AMR101 (ethyl icosapentate) - 2 g/dayDRUG

AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks

PlaceboDRUG

Placebo 4 capsules/day for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \<100 mg/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.

Locations (80)

Outcomes

Primary Outcomes

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day