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

NCT01408303 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2014-12-05

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Omthera Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Medpace, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Michael H Davidson, MD, FACC · Omthera Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01408303 on ClinicalTrials.gov