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Efficacy of TAK-085 in Participants With Hypertriglyceridemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01350973
First received: May 9, 2011
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
 Drug: TAK-085
Drug: Eicosapentaenoic acid-ethyl (EPA-E)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of TAK-085 in Subjects With Hypertriglyceridemia.

Resource links provided by NLM:

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percent change from Baseline in Triglyceride Level (Final Visit) [ Time Frame: Baseline and Final Visit (up to 12 weeks). ] [ Designated as safety issue: No ]
    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).


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 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. 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ 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 10) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ 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 10) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ 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 10) [ 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 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 or final visit relative to baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.

  • Number of Participants with Adverse Events [ Time Frame: 12 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 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after 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 8 relative to baseline. Vital signs include sitting blood pressure and pulse.

  • Change from Baseline in Vital Signs (Week 10) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: Yes ]
    Change from baseline in vital signs collected at week 10 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 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 10) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: Yes ]
    Change from baseline in participant's weight measured at week 10 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 or final visit relative to baseline.

  • Number of Participants with Abnormal Laboratory Values [ Time Frame: 12 Weeks. ] [ Designated as safety issue: Yes ]
    The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

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

  • Percent Change from Baseline in Triglyceride Level (Week 10) [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]
    The percentage change between triglycerides collected at week 10 relative to baseline.


Enrollment: 611
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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 12 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 12 weeks.
Other Names:
  • LOVAZA
  • Omacor
Experimental: EPA-E 1.8 g TID Drug: Eicosapentaenoic acid-ethyl (EPA-E)
EPA-E, 0.6 g, orally, three-times daily for up to 12 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, 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.

  Eligibility

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

Inclusion Criteria:

  1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
  2. Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Exclusion Criteria:

  1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
  2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
  3. Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
  4. Participants who have been diagnosed with pancreatitis.
  5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
  6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350973

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

No publications provided

Responsible Party: Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01350973     History of Changes
Other Study ID Numbers: TAK-085/CCT-002, JapicCTI-090972, U1111-1120-7801
Study First Received: May 9, 2011
Last Updated: February 1, 2012
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
 Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013