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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: July 28, 2016
Last verified: July 2016
  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: omega-3-acid ethyl esters 90 (TAK-085)
Drug: Eicosapentaenoic acid-ethyl (EPA)
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 Long-term Study of TAK-085 in Subjects With Hypertriglyceridemia

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.


Enrollment: 503
Study Start Date: November 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (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 52 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 52 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
Active Comparator: EPA-E 1.8 g
Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
Drug: Eicosapentaenoic acid-ethyl (EPA)
EPA-E capsules

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Visit 1 (Week -4)

  1. Undergoing lifestyle modification.
  2. Triglyceride (TG) level (fasting state) 150 mg/dL or higher and less than 750 mg/dL at Visit 1 (Week -4).
  3. Both genders, aged from 20 to less than 75 years at the time of signing informed consent.
  4. Outpatient.
  5. Capable of understanding and complying with protocol requirements.
  6. Signed a written, informed consent form prior to the initiation of any study procedures.
  7. A female with childbearing potential (premenopausal and non-sterilized) must have agreed to use routinely adequate contraception from signing of informed consent throughout the duration of the study.

    Visit 2 (Week -2)

  8. Fasting TG level 150 mg/dL or higher and less than 750 mg/dL at Visit 2 (Week -2).
  9. Difference in fasting low density lipoprotein-cholesterol (LDL-C) level between Visit 1 (Week -4) and Visit 2 (Week -2) within 25% of the higher value

Exclusion Criteria:

Visit 1 (Week -4)

  1. Any coronary artery diseases (CAD, e.g., confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -4) or a history of revascularization.
  2. Received aortic aneurysmectomy or had had aortic aneurysm within 6 months prior to Visit 1 (Week -4).
  3. History or complication of a clinically significant hemorrhagic disease (e.g., hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract haemorrhage, hemoptysis, vitreous haemorrhage) within 6 months prior to Visit 1 (Week -4).
  4. Diagnosed with pancreatitis.
  5. Diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
  6. Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
  7. Type 1 diabetes mellitus or with uncontrolled type 2 diabetes mellitus defined by glycosylated hemoglobin (HbA1C) level of 8.0% or higher at Visit 1 (Week -4).
  8. Stage III hypertension defined by systolic blood pressure of 180 mmHg or higher or diastolic blood pressure of 110 mmHg or higher regardless of the use of antihypertensive medication.
  9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level at Visit 1 (Week -4) was not less than twice the upper limit of the normal reference range.
  10. If female, was pregnant or lactating.
  11. Habitual drinking defined by an average daily alcohol intake of 100 mL or more , drug abuse or drug dependency, or a history of any of these conditions.
  12. Started to take any antihyperlipidemic drugs within 4 weeks prior to Visit 1 (Week -4).
  13. Received any investigational products (including those for post-marketing clinical study) within 12 weeks prior to Visit 1 (Week -4).
  14. Received TAK-085 in a clinical study.
  15. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

    Visit 2 (Week -2)

  16. ALT or AST level at Visit 2 (Week -2) was twice the upper limit of the normal reference range or higher.
  17. Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
  18. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons.

    Visit 3 (Week 0)

  19. Needed a change in the dose of antihyperlipidemic drugs or antidiabetic drugs, addition of a new drug or a change in the type of the drugs during the screening period.
  20. Judged as being ineligible for study participation by the investigator or subinvestigator for any other reasons
  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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01350999     History of Changes
Other Study ID Numbers: TAK-085/OCT-001  JapicCTI-090936  U1111-1120-7892  JapicCTI-R140451 
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

ClinicalTrials.gov processed this record on September 23, 2016