Clinical Trial: Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia
Brief Summary: The purpose of this study is to determine the safety and efficacy 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, open-label, randomized study to evaluate the efficacy and safety of TAK-085. In addition, EPA-E is also administered for 52 weeks for reference to evaluate the safety of TAK-085 in participants with hypertriglyceridemia who are undergoing lifestyle modification.
The study period is a total of 56 weeks, comprised of a 4- week screening period and 52 weeks of treatment.
Sponsor: Takeda
Current Primary Outcome:
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 52 Weeks ]
- Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs [ Time Frame: 52 Weeks ]
- Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight [ Time Frame: 52 Weeks ]
- Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration [ Time Frame: 52 Weeks ]Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.
- Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis [ Time Frame: 52 Weeks ]
Original Primary Outcome:
- Number of Participants with Adverse Events [ Time Frame: 52 Weeks. ]Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last dose of study drug.
- Change from Baseline in Vital Signs (Week 4) [ Time Frame: Baseline and Week 4. ]Change from baseline in vital signs collected at week 4 relative to baseline. Vital signs include sitting blood pressure and pulse.
- Change from Baseline in Vital Signs (Week 8) [ Time Frame: Baseline and Week 8. ]Change from baseline in vital signs collected at week 4 relative to baseline. Vital signs include sitting blood pressure and pulse.
- Change from Baseline in Vital Signs (Week 12) [ Time Frame: Baseline and Week 12. ]Change from baseline in vital signs collected at week 12 relative to baseline. Vital signs include sitting blood pressure and pulse.
- Change from Baseline in Vital Signs (Week 16) [ Time Frame: Baseline and Week 16. ]Change from baseline in vital signs collected at week 16 relative to baseline. Vital signs include sitting blood pressure and pulse.
- Change from Baseline in Vital Signs (Week 20) [ Time Frame: Baseline and Week 20. ]Change from baseline in vital signs collected at week 20 relative to baseline. Vital sig
Current Secondary Outcome:
- Percent Change From Baseline in Triglyceride Level [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
- Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
- Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
- Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]
- Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 ]Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.
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 Triglyceride Level (Week 12) [ Time Frame: Baseline and Week 12. ]The percentage change between triglycerides collected at week 12 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 16) [ Time Frame: Baseline and Week 16. ]The percentage change between triglycerides collected at week 16 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 20) [ Time Frame: Baseline and Week 20. ]The percentage change between triglycerides collected at week 20 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 24) [ Time Frame: Baseline and Week 24. ]The percentage change between triglycerides collected at week 24 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 28) [ Time Frame: Baseline and Week 28. ]The percentage change between triglycerides collected at week 28 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 32) [ Time Frame: Baseline and Week 32. ]The percentage change between triglycerides collected at week 32 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 36) [ Time Frame: Baseline and Week 36. ]The percentage change between triglycerides collected at week 36 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 40) [ Time Frame: Baseline and Week 40. ]The percentage change between triglycerides collected at week 40 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 44) [ Time Frame: Baseline and Week 44. ]The percentage change between triglycerides collected at week 44 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 48) [ Time Frame: Baseline and Week 48. ]The percentage change between triglycerides collected at week 48 relative to baseline.
- Percent Change from Baseline in Triglyceride Level (Week 52) [ Time Frame: Baseline and Week 52. ]The percentage change between triglycerides collected at week 52 or final visit 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.
- 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.
- 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 relative to baseline.
- Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 16) [ Time Frame: Baseline and Week 16. ]The percentage change between low-density lipoprotein cholesterol collected at week 16 relative to baseline.
- Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 20) [ Time Frame: Baseline and Week 20. ]The percentage change between low-density lipoprotein cholesterol collected at week 20 relative to baseline.
- Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 24) [ Time Frame: Baseline and Week 24. ]The percentage change between low-density lipoprotein cholesterol collected at week 24 relative to baseline.
- Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 28) [ Time Frame: Baseline and Wee
Information By: Takeda
Dates:
Date Received: May 9, 2011
Date Started: November 2009
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016
