Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: omega-3-acid ethyl esters 90 (TAK-085); Eicosapentaenoic acid-ethyl (EPA)
Intervention description: 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.; EPA-E capsules
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 503.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      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.
    

Eligibility 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