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 ezetimibe Zetia ethyl-EPA ethyl icosapentate Crestor Zocor Lipitor Niaspan LDL HDL cholesterol dyslipidemia VASCEPA icosapent ethyl
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 229
Healthy volunteers: no

Brief 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.

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

Protocol document: