Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids EPA docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin Lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin Trilipix Vytorin Simcor Niaspan ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor LDL HDL cholesterol dyslipidemia VASCEPA icosapent ethyl
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 702
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: AMR101 (ethyl icosapentate) - 4 g/day intervention 2: AMR101 (ethyl icosapentate) - 2 g/day intervention 3: Placebo
Intervention descriptions: intervention 1: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks intervention 2: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks intervention 3: Placebo 4 capsules/day for 12 weeks

Protocol document: