Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01350999
First received: May 9, 2011
Last updated: August 23, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
Drug: TAK-085
Drug: Eicosapentaenoic acid-ethyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Long-term Administration of TAK-085 to the Patients With Hypertriglyceridemia.

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 52 Weeks. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 20 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 24 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 28) [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 28 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 32 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 36 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 40 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 44) [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 44 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 48 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 52 or final visit relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Weight (Week 4) [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 4 relative to baseline.

  • Change from Baseline in Weight (Week 8) [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 8 relative to baseline.

  • Change from Baseline in Weight (Week 12) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 12 relative to baseline.

  • Change from Baseline in Weight (Week 16) [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 16 relative to baseline.

  • Change from Baseline in Weight (Week 20) [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 20 relative to baseline.

  • Change from Baseline in Weight (Week 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 24 relative to baseline.

  • Change from Baseline in Weight (Week 28) [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 28 relative to baseline.

  • Change from Baseline in Weight (Week 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 32 relative to baseline.

  • Change from Baseline in Weight (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 36 relative to baseline.

  • Change from Baseline in Weight (Week 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 40 relative to baseline.

  • Change from Baseline in Weight (Week 44) [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 44 relative to baseline.

  • Change from Baseline in Weight (Week 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 48 relative to baseline.

  • Change from Baseline in Weight (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 52 or final visit relative to baseline.

  • Change from Baseline in Electrocardiograms (Week 12) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]
    Change from baseline in electrocardiogram measured at week 12 relative to baseline.

  • Change from Baseline in Electrocardiograms (Week 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: Yes ]
    Change from baseline in electrocardiogram measured at week 24 relative to baseline.

  • Change from Baseline in Electrocardiograms (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: Yes ]
    Change from baseline in electrocardiogram measured at week 36 relative to baseline.

  • Change from Baseline in Electrocardiograms (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: Yes ]
    Change from baseline in electrocardiogram measured at week 52 or final visit relative to baseline.

  • Number of Participants with Abnormal Laboratory Values [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.


Secondary Outcome Measures:
  • Percent Change from Baseline in Triglyceride Level (Week 4) [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 Week 28. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 28 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 32 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 36 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 40 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 44) [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 44 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 48 relative to baseline.

  • Percent Change from Baseline in Low-Density Lipoprotein - Cholesterol Level (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]
    The percentage change between low-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 4) [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 8 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 12) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 12 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 16) [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 16 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 20) [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 20 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 24 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 28) [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 28 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 32 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 36 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 40 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 44) [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 44 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 48 relative to baseline.

  • Percent Change from Baseline in Total Cholesterol (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]
    The percentage change between total cholesterol measured at week 52 or final visit relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 4) [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 12) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 12 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 16) [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 16 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 20) [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 20 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 24 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 28) [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 28 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 32 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 36 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 40 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 44) [ Time Frame: Baseline and Week 44. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 44 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 48 relative to baseline.

  • Percent Change from Baseline in High-Density Lipoprotein - Cholesterol Level (Week 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]
    The percentage change between high-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline.

  • Percent Change from Baseline in Non-High-Density Lipoprotein - Cholesterol Level (Week 4) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 10 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. ] [ Designated as safety issue: No ]
    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 12) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 12 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 16) [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 16 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 20) [ Time Frame: Baseline and Week 20. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 20 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 24) [ Time Frame: Baseline and Week 24. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 24 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 28) [ Time Frame: Baseline and Week 28. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 28 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 32) [ Time Frame: Baseline and Week 32. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 32 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 36) [ Time Frame: Baseline and Week 36. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 36 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 40) [ Time Frame: Baseline and Week 40. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 40 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 48) [ Time Frame: Baseline and Week 48. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 48 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 52) [ Time Frame: Baseline and Week 52. ] [ Designated as safety issue: No ]
    The percentage change between non-high-density lipoprotein cholesterol collected at week 52 or final visit relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.


Enrollment: 503
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-085 2 g QD Drug: TAK-085
TAK-085 2 g, capsules, orally, once daily for up to 52 weeks.
Other Names:
  • LOVAZA
  • Omacor
Experimental: TAK-085 2 g BID Drug: TAK-085
TAK-085 2 g, capsules, orally, twice daily for up to 52 weeks.
Other Names:
  • LOVAZA
  • Omacor
Active Comparator: EPA-E 0.6 g TID Drug: Eicosapentaenoic acid-ethyl
EPA-E 0.6 g, capsules, orally, three-times daily for up to 52 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350999

Sponsors and Collaborators
Takeda
Investigators
Study Director: Associate Professor, Clinical Cell Biology and Medicine Graduate School of Medicine, Chiba University
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01350999     History of Changes
Other Study ID Numbers: TAK-085/OCT-001, JapicCTI-090936, U1111-1120-7892
Study First Received: May 9, 2011
Last Updated: August 23, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Hypertriglyceridemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014