CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 646 enrolled
Drug / intervention
Olive oil, 4g +2 moredrug
Likely dose
Olive oil, 4gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01408303
NCT01408303Phase 3Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Aug 3, 2011·Updated Dec 5, 2014

In Brief

A Phase 3 clinical trial evaluating Olive oil, 4g, omega-3-carboxylic acids, 2g, and 1 other intervention for Hypertriglyceridemia and Cardiovascular Disease. Completed, enrolled 646 participants across 89 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertriglyceridemia, Cardiovascular Disease
CountriesUnited States
CollaboratorsOmthera Pharmaceuticals, Inc, Medpace, Inc.

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2011
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.9 years ago

Interventions

Olive oil, 4gdrug

Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin

omega-3-carboxylic acids, 2gdrug

Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin

omega-3-carboxylic acids, 4gdrug

Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin