Study identifier:OM-EPA-004
ClinicalTrials.gov identifier:NCT01408303
EudraCT identifier:N/A
CTIS identifier:N/A
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
Hypertriglyceridemia
Phase 3
No
Olive oil, 4g, omega-3-carboxylic acids, 2g, omega-3-carboxylic acids, 4g
All
646
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
Omthera Pharmaceuticals, Inc., Medpac, Inc.
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.
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).
Location
Location
Muscle Shoals, Alabama, United States, 35662
Location
Chandler, Arizona, United States, 85224
Location
Phoenix, Arizona, United States, 85020
Location
Little Rock, Arkansas, United States, 72205
Location
Encinitas, California, United States, 92024
Location
Lomita, California, United States, 90717
Location
Los Angeles, California, United States, 90057
Location
Sacramento, California, United States, 95823
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Olive Oil olive oil: 4 g/day + prescription statin | Drug: Olive oil, 4g Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin Other Name: Placebo comparator |
Experimental: Epanova, 2 g omega-3-carboxylic acids, 2g/day + 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 Other Name: omega-3-carboxylic acids |
Experimental: Epanova, 4 g omega-3-carboxylic acids, 4g/day + prescription statin | Drug: omega-3-carboxylic acids, 4g Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin Other Name: omega-3-carboxylic acids |
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