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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™

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ClinicalTrials.gov Identifier: NCT00891293
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : July 28, 2009
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE April 30, 2009
First Posted Date  ICMJE May 1, 2009
Results First Submitted Date  ICMJE May 6, 2009
Results First Posted Date  ICMJE July 28, 2009
Last Update Posted Date January 25, 2011
Study Start Date  ICMJE March 2006
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
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). [ Time Frame: Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
Median Percent Change in Serum Triglycerides from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Serum Triglycerides from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
Difference between the within-group mean percent change (from baseline) in Triglyceride (TG) level observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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). [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in Total Cholesterol (Total-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of Total-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in very low density lipoprotein-cholesterol (VLDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of VLDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in low density lipoprotein-cholesterol (LDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of LDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in the ratio of total cholesterol (Total-C) to high density lipoprotein-cholesterol (HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change for the ratio of Total-C to HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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 [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in apolipoprotein (apo) A-1 from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo A-1 from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change in apolipoprotein (apo) B from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of apo B from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
  • 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) [ Time Frame: LOV111859/OM5 Baseline to LOV111860/OM5X Week 8 and LOV111859/OM5 Baseline to LOV111821/OM5XX Month 24 ]
    Median Percent Change of non- high density lipoprotein-cholesterol (non-HDL-C) from the baseline of LOV111859/OM5 to the End-of-Treatment (EOT) (Week 8) of LOV111860/OM5X and Median Percent Change of non-HDL-C from the baseline of LOV111859/OM5 to the EOT (Month 24) of LOV111821/OM5XX.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • Difference between the within-group mean percent change (from baseline) in Total Cholesterol (TC) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in Very-Low Density Lipoprotein-Cholestorol (VLDL-C) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in Low Density Lipoprotein-Cholesterol (VLDL-C) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in High Density Lipoprotein-Cholesterol (HDL-C) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in TC/HDL-C ratio observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in Apolipoprotein A-1 (Apo A-1) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • Difference between the within-group mean percent change (from baseline) in Apolipoprotein B (Apo B) observed at the end of LOV111860/OM5X and mean percent change (from baseline) observed at the end of LOV111821/OM5XX [ Time Frame: 24 months ]
  • For the above lipid parameters, additional time points may be added [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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™
Official Title  ICMJE 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™
Brief Summary 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.
Detailed Description

Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd open label extension - 24 months).

Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertriglyceridemia
Intervention  ICMJE Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Study Arms  ICMJE Experimental: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]
Intervention: Drug: Antara (fenofibrate) + Lovaza (omega-3-acid ethyl esters)
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(3):196-203. doi: 10.1097/FJC.0b013e3181b0cf71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
93
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891293
Other Study ID Numbers  ICMJE 111821
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP