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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Simvastatin
Simvastatin + Lovaza
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring omega-3-acid ethyl esters, simvastatin, Lovaza, High triglycerides

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Simvastatin

    Simvastatin + Lovaza

    Arm Description

    Simvastatin + placebo

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

    Outcomes

    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

    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

    Full Information

    First Posted
    October 28, 2005
    Last Updated
    March 24, 2017
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00246701
    Brief Title
    Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects
    Acronym
    COMBOS
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Omacor and Simvastatin Therapy in Hypertriglyceridemic Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2005 (Actual)
    Primary Completion Date
    June 1, 2006 (Actual)
    Study Completion Date
    June 1, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertriglyceridemia
    Keywords
    omega-3-acid ethyl esters, simvastatin, Lovaza, High triglycerides

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    256 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Simvastatin
    Arm Type
    Active Comparator
    Arm Description
    Simvastatin + placebo
    Arm Title
    Simvastatin + Lovaza
    Arm Type
    Experimental
    Arm Description
    Simvastatin + Lovaza (omega-3-acid ethyl esters)
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Intervention Description
    Simvastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin + Lovaza
    Intervention Description
    Simvastatin + Lovaza (omega-3-acid ethyl esters)
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20451686
    Citation
    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.
    Results Reference
    derived

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

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