Clinical Trial: Efficacy of TAK-085 in Participants With Hypertriglyceridemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Brief Summary: The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Detailed Summary:

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.


Sponsor: Takeda

Current Primary Outcome: Percent Change From Baseline in Triglyceride Level at the Final Visit [ Time Frame: Baseline and 12 weeks ]

The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.


Original Primary Outcome: Percent change from Baseline in Triglyceride Level (Final Visit) [ Time Frame: Baseline and Final Visit (up to 12 weeks). ]

The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to baseline. Values defined as follows: Baseline= the mean of the values at Weeks -4, -2 and 0; End of study drug administration= the mean of values at Weeks 10 and 12 (as a general rule, the mean of values at Week 10 and 12 will be used, but in case of withdrawal, the mean of the last 2 evaluable values will be used; if the time interval of the last 2 evaluable values is more than 2 weeks apart, only the last evaluable value will be used).


Current Secondary Outcome:

  • Percent Change From Baseline in Triglyceride Level Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ]
    The percentage change between triglycerides collected at each study visit relative to Baseline.
  • Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ]
    The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
  • Percent Change From Baseline in Total Cholesterol Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ]
    The percentage change between total cholesterol measured at each study visit relative to Baseline.
  • Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ]
    The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.
  • Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ]
    The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 12 Weeks ]
  • Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs [ Time Frame: 12 Weeks ]
  • Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis [ Time Frame: 12 Weeks ]
  • Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration [ Time Frame: 12 Weeks ]


Original Secondary Outcome:

  • Percent Change from Baseline in Triglyceride Level (Week 4) [ Time Frame: Baseline and Week 4. ]
    The percentage change between triglycerides collected at week 4 relative to baseline.
  • Percent Change from Baseline in Triglyceride Level (Week 8) [ Time Frame: Baseline and Week 8. ]
    The percentage change between triglycerides collected at week 8 relative to baseline.
  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 4) [ Time Frame: Baseline and Week 4. ]
    The percentage change between low-density lipoprotein cholesterol collected at week 4 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 8) [ Time Frame: Baseline and Week 8. ]
    The percentage change between low-density lipoprotein cholesterol collected at week 8 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 10) [ Time Frame: Baseline and Week 10. ]
    The percentage change between low-density lipoprotein cholesterol collected at week 10 relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 12) [ Time Frame: Baseline and Week 12. ]
    The percentage change between low-density lipoprotein cholesterol collected at week 12 or final visit relative to baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.
  • Percent Change from Baseline in Total Cholesterol (Week 4) [ Time Frame: Baseline and Week 4. ]
    The percentage change between total cholesterol measured at week 4 relative to baseline.
  • Percent Change from Baseline in Total Cholesterol (Week 8) [ Time Frame: Baseline and Week 8. ]
    The percentage change between total cholesterol measured at week 8 relative to baseline.
  • Percent Change from Baseline in Total Cholesterol (Week 10) [ Time Frame: Baseline and Week 10. ]
    The percentage change between total cholesterol measured at week 10 relative to baseline.
  • Percent Change from Baseline in Total Cholesterol (Week 12) [ Time Frame: Baseline and Week 12. ]
    The percentage change between total cholesterol measured at week 12 or final visit relative to baseline.
  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 4) [ Time Frame: Baseline and Week 4. ]
    The percentage change between high-density lipoprotein cholesterol collected at week 4 relative to baseline.
  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 8) [ Time Frame: Baseline and Week 8. ]
    The percentage change between high-density lipoprotein cholesterol collected at week 8 relative to baseline.
  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 10) [ Time Frame: Baseline and Week 10. ]
    The percentage change between high-density lipoprotein cholesterol collected at week 10 relative to baseline.
  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 12) [ Time Frame: Baseline and Week 12. ]
    The percentage change between high-density lipoprotein cholesterol collected at week 12 or final visit relative to baseline.
  • Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 4) [ Time Frame: Baseline and Week 4 ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 4 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
  • Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 8) [ Time Frame: Baseline and Week 8. ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 8 relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
  • Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 10) [ Time Frame: Baseline a

    Information By: Takeda

    Dates:
    Date Received: May 9, 2011
    Date Started: November 2009
    Date Completion:
    Last Updated: July 28, 2016
    Last Verified: July 2016