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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00246701
First received: October 28, 2005
Last updated: December 10, 2009
Last verified: December 2009

October 28, 2005
December 10, 2009
November 2005
June 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Change in non-high-density lipoprotein cholesterol
Complete list of historical versions of study NCT00246701 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Changes in other lipid and biomarker levels
Not Provided
Not Provided
 
Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: Simvastatin + Lovaza
    Simvastatin + Lovaza (omega-3-acid ethyl esters)
  • Drug: Simvastatin
    Simvastatin
  • Active Comparator: Simvastatin
    Simvastatin + placebo
    Intervention: Drug: Simvastatin
  • Experimental: Simvastatin + Lovaza
    Simvastatin + Lovaza (omega-3-acid ethyl esters)
    Intervention: Drug: Simvastatin + Lovaza
Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am J Cardiol. 2010 May 15;105(10):1409-12. doi: 10.1016/j.amjcard.2009.12.063. Epub 2010 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
June 2006
June 2006   (final data collection date for primary outcome measure)

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)
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00246701
OM6 program (Reliant), LOV111858 (OM6)
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP