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Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects — COMBOS  

Hypertriglyceridemia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Clinical Trial Summary

The purpose of OM6 is to evaluate efficacy and safety of Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] combined with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HDL-C) in subjects with persistent high triglycerides despite statin therapy.

Additionally, a two-year extension trial (LOV111818/OM6X) is posted on NCT00903409.

Clinical Trial Description

Two studies comprise this OM6 Program. Study OM6 / LOV111858 (double-blind study) and is not required to post results based on FDAAA. Study OM6X / LOV111818 (open-label extension) is posted on NCT00903409. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00246701
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date November 1, 2005
Completion date June 1, 2006
View Details
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