Conditions: Hypertriglyceridemia Cardiovascular Disease
Keywords: dyslipidemia hyperlipidemia cardiovascular risk
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 646
Healthy volunteers: no

Brief summary:
The primary objective is to evaluate the efficacy of adding Epanova (2 g or 4 g daily) to an optimal statin monotherapy for lowering non-high-density lipoprotein (non-HDL) cholesterol in subjects with persistent hypertriglyceridemia and high risk for cardiovascular disease.

Detailed description:
The primary efficacy variable is serum non-HDL cholesterol. The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups. Baseline is defined as the average of Visits 2, 3 and 4 (Weeks -2, -1 and 0) and end-of-treatment is the average of Visits 5 and 6 (Weeks 5 and 6).

Arms:
arm 1: olive oil: 4 g/day + prescription statin arm 2: omega-3-carboxylic acids, 2g/day + prescription statin arm 3: omega-3-carboxylic acids, 4g/day + prescription statin

Interventions: intervention 1: Olive oil, 4g intervention 2: omega-3-carboxylic acids, 2g intervention 3: omega-3-carboxylic acids, 4g
Intervention descriptions: intervention 1: Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin intervention 2: Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin intervention 3: Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin

Protocol document: