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