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Efficacy of TAK-085 in Participants With Hypertriglyceridemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01350973
First received: May 9, 2011
Last updated: July 28, 2016
Last verified: July 2016
  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: Omega-3-acid ethyl esters 90 (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:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percent Change From Baseline in Triglyceride Level at the Final Visit [ Time Frame: Baseline and 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. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.


Secondary Outcome Measures:
  • Percent Change From Baseline in Triglyceride Level Over Time [ Time Frame: Baseline and Weeks 4, 8, 10 and 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

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
TAK-085 2 g, orally, once daily for up to 12 weeks.
Drug: Omega-3-acid ethyl esters 90 (TAK-085)
Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
Other Names:
  • LOVAZA
  • Omacor
Experimental: TAK-085 4 g
TAK-085 2 g, orally, twice daily for up to 12 weeks.
Drug: Omega-3-acid ethyl esters 90 (TAK-085)
Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
Other Names:
  • LOVAZA
  • Omacor
Experimental: EPA-E 1.8 g
Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
Drug: Eicosapentaenoic acid-ethyl (EPA-E)
EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
Other Name: Atheropan®

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   (Adult, Senior)
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
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: NCT01350973

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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01350973     History of Changes
Other Study ID Numbers: TAK-085/CCT-002  JapicCTI-090937  U1111-1120-7801  JapicCTI-R140452 
Study First Received: May 9, 2011
Results First Received: June 1, 2016
Last Updated: July 28, 2016
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

ClinicalTrials.gov processed this record on December 07, 2016