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Evaluation of Efficacy and Safety of Omacor (Omega-3-acid Ethyl Esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated With Antara (Fenofibrate) Followed by an 8-week Extension

NCT00246636 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2009-12-14

No results posted yet for this study

Summary

The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.

The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Antara (fenofibrate) + Lovaza

Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\]

DRUG

Antara (fenofibrate)

Antara (fenofibrate) + placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2007-02-28
Completion
2007-03-31

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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 NCT00246636 on ClinicalTrials.gov