Skip to main content
OpenTrials
Completed

NCT Number: NCT00246701

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women ages 18-79 years, inclusive
  • Current therapy with a statin drug
  • Triglyceride levels between 200 and 499 mg/dL
  • Normally active and in good health on the basis of medical history, brief physical examination, electrocardiogram, and routine laboratory tests
  • Provide written informed consent and authorization for protected health information disclosure

Exclusion criteria

  • Sensitivity to statin drugs or omega-3 fatty acids
  • Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
  • Unexplained muscle pain or weakness
  • History of pancreatitis
  • Recent history of certain heart, kidney, liver, lung, or gastrointestinal diseases, or cancer (except non-melanoma skin cancer)
  • Poorly controlled diabetes, or receiving insulin therapy
  • Pregnant or lactating females. Women of childbearing potential who are not using a medically approved method of contraception.
  • Use of certain types of hormones, anticonvulsant drugs, immunologic drugs, antibiotic, antifungal and antiviral drugs, and cardiac drugs
  • Use of warfarin (Coumadin)

Treatment and study plan

simvastatin

Drug

Simvastatin

Simvastatin + Lovaza

Drug

Simvastatin + Lovaza (omega-3-acid ethyl esters)

Primary outcomes

  1. Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in non-high-density lipoprotein cholesterol

    Time frame: 8 weeks

Secondary outcomes

  1. OM6/LOV111858 - Difference between simvastatin + Lovaza (omega-3-acid ethyl esters) and simvastatin + placebo treatment groups in the percent change from baseline to end-of-treatment in other lipid and biomarker levels

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Acronym: COMBOS

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 31, 2005
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.