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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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Antara (fenofibrate) + Lovaza
Antara (fenofibrate)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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: Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation Successfully completed the previous OM5 double-blind study to Week 8 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    OM5/LOV111859 (double-blind study) - Antara

    OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza

    OM5/LOV111859 (double-blind study) - Antara + Lovaza

    Arm Description

    Antara (fenofibrate) + placebo

    Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]

    Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]

    Outcomes

    Primary Outcome Measures

    OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X
    OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline

    Secondary Outcome Measures

    OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X
    OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline

    Full Information

    First Posted
    October 28, 2005
    Last Updated
    December 10, 2009
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00246636
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    February 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    Three studies comprise this OM5 Program Study OM5 / LOV111859 (double-blind study) and OM5X / LOV111860 (1st open-label extension) are part of this listing on ClinicalTrials.gov - NCT00246636. Study OM5XX / LOV111821 (2nd open-label extension) is listed as a separate listing on ClinicalTrials.gov - NCT00891293

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    167 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    OM5/LOV111859 (double-blind study) - Antara
    Arm Type
    Active Comparator
    Arm Description
    Antara (fenofibrate) + placebo
    Arm Title
    OM5X/LOV111860 (extension study) - Open-Label Antara + Lovaza
    Arm Type
    Experimental
    Arm Description
    Open-label Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
    Arm Title
    OM5/LOV111859 (double-blind study) - Antara + Lovaza
    Arm Type
    Experimental
    Arm Description
    Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
    Intervention Type
    Drug
    Intervention Name(s)
    Antara (fenofibrate) + Lovaza
    Intervention Description
    Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
    Intervention Type
    Drug
    Intervention Name(s)
    Antara (fenofibrate)
    Intervention Description
    Antara (fenofibrate) + placebo
    Primary Outcome Measure Information:
    Title
    OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change in fasting serum TG level from baseline of OM5 to end of OM5X
    Time Frame
    8 weeks
    Title
    OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]+ fenofibrate and placebo + fenofibrate treatment groups in percent change in TG level from baseline
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    OM5X/LOV111860 - Difference between double-blind Lovaza (omega-3-acid ethyl esters) + fenofibrate (Group 1) and placebo + fenofibrate (Group 2) treatment groups in percent change for other lipid and biomarkers from baseline of OM5 to end of OM5X
    Time Frame
    8 weeks
    Title
    OM5/LOV111859 - Difference between Lovaza (omega-3-acid ethyl esters) + fenofibrate and placebo + fenofibrate treatment groups in percent change for other lipid and biomarkers from baseline
    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
    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: Satisfied all inclusion and exclusion criteria prior to and throughout the previous OM5 study or had a corresponding approved protocol deviation Successfully completed the previous OM5 double-blind study to Week 8 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)
    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
    19820283
    Citation
    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 Sep;121(5):145-50. doi: 10.3810/pgm.2009.09.2061.
    Results Reference
    derived
    PubMed Identifier
    19597368
    Citation
    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 hypertriglyceridemic subjects. J Cardiovasc Pharmacol. 2009 Sep;54(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.
    Results Reference
    derived

    Learn more about this trial

    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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