Last updated: 11/07/2018 18:01:54

Evaluation of Efficacy and Safety of Combined Omacor (omega-3-acid ethyl esters) and Simvastatin Therapy in Hypertriglyceridemic SubjectsCOMBOS

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GSK study ID
OM6 program (Reliant)
See study documents
Clinicaltrials.gov ID
NCT00246701
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean percent change from baseline to the end-of-treatment (EOT) for simvastatin+omacor and simvastatin+placebo treatment groups in non-high-density lipoprotein cholesterol (non-HDL-C)

Timeframe: Baseline (average of Wks -2, -1, and 0) and EOT (average of Wk 6 and Wk 8)

Secondary outcomes:

Mean percent change from baseline to the end-of-treatment (EOT) for simvastatin + omacor and simvastatin + placebo treatment groups in triglycerides, total cholesterol, calculated VLDL-C, LDL-C, HDL-C, Apo A-I, and Apo B lipid and biomarker levels

Timeframe: Baseline (average of Wks -2, -1, and 0) and EOT (average of Wk 6 and Wk 8)

Mean percent change from baseline to the EOT for simvastatin + omacor and simvastatin + placebo treatment groups in the ratio of total to the HDL- cholesterol

Timeframe: Baseline (average of Wks -2, -1, and 0) and EOT (average of Wk 6 and Wk 8)

Interventions:
  • Drug: Simvastatin
  • Drug: Simvastatin + Lovaza
    • Enrollment:
    256
    Primary completion date:
    2006-23-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Ballantyne C, Bays H, Davidson M, Maki K, Carter R. Lipoprotein Effects of Prescription Omega-3 Ethyl Esters and Simvastattin versus Simvastatin Alone Secondary Manuscript. [J Clin Lipidol]. 2009;3(5):332-40.
    Davidson M, Stein E, Bays H, Maki K, Doyle R, Shalwitz R, Ballantyne C, Ginsberg H; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators.Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2007;29:1354-67.
    Maki KC, Davidson MH, Doyle RT, Ballantyne C. Effect of Prescription Omega-3 Fatty Acids on Non-HDL Cholesterol (Stratified by Baseline LDL Cholesterol Level) in Statin-Treated Patients With Hypertriglyceridemia: COMBOS LDL Tertile Analysis Short Clinical Communication . [Am J Cardiol]. 2010;105(10):1409-12.
    Maki KC, Dicklin M, Davidson M, Doyle R, Ballantyne C . Baseline Lipoprotein Lipids and the Low-Density Lipoprotein Cholesterol Response to Prescription Omega-3 Acid Ethyl Ester Therapy. [Am J Cardiol]. 2010;105(May):1409-1412.
    Medical condition
    Hypertriglyceridemia
    Product
    GI104000, GSK2295313, omega-3-acid ethyl esters
    Collaborators
    Not applicable
    Study date(s)
    May 2005 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • Men and women ages 18-79 years, inclusive
    • Sensitivity to statin drugs or omega-3 fatty acids
    • Lipoprotein lipase impairment or apo C-2 deficiency or type III hyperlipidemia
    Inclusion and exclusion 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)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-23-06
    Actual study completion date
    2006-23-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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