NCT01408303

[E]PANOVA Combined With a [S]TATIN in [P]ATIENTS With HYPERT[R]IGLYCER[I]DEMIA to Reduce Non-HDL CHOLES[T]EROL

A 6-Week, Randomized, Double-Blind, Placebo(Olive Oil)-Controlled Study to Assess the Efficacy and Safety of Add-On Epanova® to Statin Therapy in Subjects With Persistent Hypertriglyceridemia and High Risk for Cardiovascular Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 646 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertriglyceridemia
• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Olive oil, 4g	Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
DRUG	omega-3-carboxylic acids, 2g	Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
DRUG	omega-3-carboxylic acids, 4g	Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-08-03
• Last updated: 2014-12-05
• Results posted: 2014-12-05

Locations

89 sites across 1 country: United States