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
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    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
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    Location
    GSK Investigational Site
    Bloomington, Indiana, United States, 47403
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95831
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greenbrae, California, United States, 94904
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hickory, North Carolina, United States, 28601
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dunwoody, Georgia, United States, 30328
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45246
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Encinitas, California, United States, 92024
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Thousand Oaks, California, United States, 91360
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hollywood, Florida, United States, 33023
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Salisbury, North Carolina, United States, 28144
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40213
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wentzville, Minnesota, United States, 62285
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lakewood, Washington, United States, 98499
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23249
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98104
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Statesville, North Carolina, United States, 28677
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28412
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Warwick, Rhode Island, United States, 02886
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60610
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19111
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10032
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46260
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pinellas Park, Florida, United States, 33781
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Edina, Minnesota, United States, 55435
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30309
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45212
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23502
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Plano, Texas, United States, 75093
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93710
    Status
    Terminated/Withdrawn
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    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.

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