Last updated: 11/07/2018 18:01:33

Evaluation of Efficacy and Safety of Omacor (omega-3-acid ethyl esters) as Add-on Therapy in Hypertriglyceridemic Subjects Treated with Antara (fenofibrate) followed by an 8-week extension

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GSK study ID
OM5 program (Reliant)
See study documents
Clinicaltrials.gov ID
NCT00246636
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, Parallel-Group, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Omacor Therapy in Hypertriglyceridemic Subjects Treated with Antara, followed by an 8-week extension
Trial description: The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of patients with very high triglycerides.
The purpose of both OM5X/LOV111860 was to assess the continued efficacy and safety of adjunctive Lovaza (omega-3-acid ethyl esters) therapy in hypertriglyceridemic subjects treated with fenofibrate in lowering serum triglyceride (TG) levels.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in fasting serum triglyceride (TG) level

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in serum TG level

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Secondary outcomes:

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers- Myeloperoxidase (MPO) and Lipoprotein Associated Phospholipase A2

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers- MPO and Lipoprotein Associated Phospholipase A2

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers: C-Reactive Protein-Cardiac

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers: C-Reactive Protein-Cardiac

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers- Homeostatic model assessment for insulin resistance (HOMA-IR)

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers- HOMA-IR

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers- Homocysteine, Total Fructosamine, Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA) and Arachidonic Acid

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers- Homocysteine, Total Fructosamine, EPA, DHA and Arachidonic Acid

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Percent change from Baseline of OM5 to end of OM5 double-blind treatment in other lipid and biomarkers- Total fatty acids

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 6 and 8)

Percent change from Baseline of study OM5 to the end of OM5X open-label treatment in other lipid and biomarkers- Total fatty acids

Timeframe: Baseline (average of Week -2, Week -1 and Week 0) to End of treatment (average of Week 14 and 16)

Interventions:
  • Drug: Antara (fenofibrate)
  • Drug: Antara (fenofibrate) + Lovaza
    • Enrollment:
    167
    Primary completion date:
    2007-28-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bays HE, Maki KC, Doyle RT, Stein E. . The effect of prescription omega-3 fatty acids on body weight after 8 to 16 weeks of treatment for very high triglyceride levels. . Postgrad Med. 2009;121(5):145-50.
    Roth EM, Bays HE, Forker AD, Maki KC, Carter R, Doyle RT, Stein EA. Prescription Omega-3 Fatty Acid as an Adjunct to Fenofibrate Therapy in Hypertrigylceridemic Subjects. J Cardiovasc Pharmacol. 2009;54(3):196-203.
    Medical condition
    Hypertriglyceridemia
    Product
    GI104000, GSK2295313, omega-3-acid ethyl esters
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to February 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • For OM5/LOV111858 -
    • Inclusion Criteria:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • For OM5/LOV111858
    • Inclusion Criteria:
    • Men and women ages 18-79 years, inclusive
    • Triglyceride levels between 500 mg/dL and <1300 mg/dL
    • Body mass index between 25 and 43 kg/m2
    • Willingness to follow a low-saturated fat diet during the study period and maintain current physical activity level
    • 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 fibrate drugs or omega-3 fatty acids
    • Lipoprotein lipase impairment or apo C-2 deficiency or Type III hyperlipidemia
    • History of pancreatitis
    • Recent history of certain kidney, liver, lung, or gastrointestinal disease or cancer (except non-melanoma skin cancer)
    • Poorly controlled diabetes mellitus
    • Type 1 diabetes
    • 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 isotretinoin (Accutane)
    • Use of warfarin (Coumadin) For OM5X/LOV111859
    • Subjects were included in the study if they met the following criteria: 1. Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation 2. Successfully completed the previous OM5 double-blind study to Week 8 3. Provided written informed consent on or before the Week 8 clinic visit of the OM5 double-blind study (i.e., Visit 1X of the OM5X extension study)

    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
    2007-28-02
    Actual study completion date
    2007-28-02

    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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