Last updated: 11/07/2018 04:00:48

Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects

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GSK study ID
111818
See study documents
Clinicaltrials.gov ID
NCT00903409
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: OM6X: An Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Combined Lovaza (previously Omacor®) and Simvastatin Therapy in Hypertriglyceridemic Subjects
Trial description: In a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Median Percent Change of Non-HDL-C (High Density Lipoprotein-Cholesterol) in Switchers vs. Non-Switchers subjects from LOV111858 End-of-Treatment (Week 8) to Month 4 of Extension Study (LOV111818)

Timeframe: Month 4 (LOV111818)

Secondary outcomes:

Median Percent Change of Lipid Measurements from LOV111858 End-of-Treatment Week 8 to Months 4, 12, and 24 of the Open-Label Extension Study (LOV111818) in “Switchers” vs. Non-switchers

Timeframe: Months 4, 12, and 24 (LOV111818) of the open-label extension trial

Median Percent Change of Lipid Measurements from LOV111858 End-of-Treatment Week 8 to LOV111818 Months 4, 12, and 24 of the Open-Label Extension Trial

Timeframe: LOV111858 End-of-Treatment (Week 8) to LOV111818 Months 4, 12, and 24 of the open-label extension trial

Interventions:
  • Drug: Simvastatin + Lovaza® (omega-3-acid ethyl esters)
    • Enrollment:
    188
    Primary completion date:
    2008-27-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bays H, Maki K, McKenney J, et al. Long-term Efficacy of Prescription Omega-3 Fatty Acids Co-administered With Simvastatin in Hypertriglyceridemic Patients. Current Medical Research & Opinion (CMRO) Vol. 26, No. 4, 2010, 907–915.
    Bays H, Maki K, McKenney JM, Snipes, R, Meadowcroft A, Schroyer R, Doyle R, Stein E. Long Term Efficacy and Safety of Prescription Omega-3 Acid Ethyl Esters and Simvastatin in Patients with Hypertriglyceridemia: Open Label Extension of a Randomized, Double-Blind Placebo-Controlled Study Primary Manuscript. [Curr Med Res Opin]. 2010;26(4):907-915.
    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 low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. . [Am J Cardiol]. 2010;105(May):1409-1412.
    Medical condition
    Hypertriglyceridemia
    Product
    GI104000, GSK2295313, omega-3-acid ethyl esters
    Collaborators
    GSK
    Study date(s)
    November 2005 to June 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • For LOV111818/OM6X -
    • Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For LOV111818/OM6X
    • Subjects were included in the study if they had met all relevant inclusion/exclusion criteria prior to and throughout the double-blind Study LOV111858/OM6 and completed Study LOV111858/OM6 to Week 8. FYI
    • entry criteria for LOV111818/OM6 (double-blind study) 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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23294
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mobile, Alabama, United States, 36608
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33606
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Suwanee, Georgia, United States, 30024
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Bloomington, Indiana, United States, 47403
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 40 Results

    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
    2008-27-06
    Actual study completion date
    2008-27-06

    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

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