Last updated: 11/03/2018 12:16:01

A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (formerly known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated with Antara™

GSK study ID
111821
See study documents
Clinicaltrials.gov ID
NCT00891293
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 Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (formerly known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated with Antara™
Trial description: This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Percent Change in serum triglycerides from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension).

Timeframe: Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Secondary outcomes:

Percent Change in total cholesterol from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study).

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in VLDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in LDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in ratio of Total-C:HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL ext. study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in apo A-1 from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in apo B from LOV111859/OM5 (double-blind [DB[ study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Percent Change in non-HDL-C from LOV111859/OM5 (double-blind [DB] study) Baseline to Week 8 of LOV111860/OM5X (1st open-label [OL] extension study) and from LOV111859/OM5 (DB study) Baseline to Month 24 of LOV111821/OM5XX (2nd OL extension study)

Timeframe: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24

Interventions:
  • Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
    • Enrollment:
    93
    Primary completion date:
    2008-07-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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 54:196-203.
    TENTATIVE: 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)
    March 2006 to May 2008
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.
    • Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol. Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,
    • 18 to79 years of age (inclusive) at screening
    • fasting serum TG levels ≥500 mg/dL and <1300 mg/dL
    • BMI ≥ 25 kg/m2 and ≤43 kg/m2. Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Statesville, North Carolina, United States, 28677
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Wentzville, Minnesota, United States, 62285
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Spring Valley, California, United States, 91978
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23294
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20037
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 32 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
    2008-07-05
    Actual study completion date
    2008-07-05

    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website