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Epanova® for Lowering Very High Triglycerides

NCT01242527 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2016-08-04

Study results available
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Summary

The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

Conditions

Interventions

DRUG

placebo

4 capsules (1g) daily for 12 weeks

DRUG

omefas

2 capsules (1g) + 2 placebo daily for 12 weeks

DRUG

omefas

3 capsules (1g) + 1 placebo daily for 12 weeks

DRUG

omefas

4 capsules (1g)daily for 12 weeks

Sponsors & Collaborators

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
2011-01-31
Primary Completion
2012-03-31
Completion
2012-04-30

Countries

  • United States
  • Denmark
  • Hungary
  • India
  • Netherlands
  • Russia
  • Ukraine

Study Locations

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Entities

Drugs
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 NCT01242527 on ClinicalTrials.gov