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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
 Drug: Simvastatin + Lovaza
Drug: Simvastatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 256
Study Start Date: November 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Simvastatin
Simvastatin + placebo
 Drug: Simvastatin
Simvastatin
Experimental: Simvastatin + Lovaza
Simvastatin + Lovaza (omega-3-acid ethyl esters)
 Drug: Simvastatin + Lovaza
Simvastatin + Lovaza (omega-3-acid ethyl esters)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246701

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00246701     History of Changes
Other Study ID Numbers: OM6 program (Reliant), LOV111858 (OM6)
Study First Received: October 28, 2005
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
High triglycerides
omega-3-acid ethyl esters
simvastatin
Lovaza

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013