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
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
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014