Exploratory Study of the Effect of Omega-3-acid Ethyl Esters (TAK-085) on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: TAK-085
Intervention description: TAK-085 capsules
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on
      vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients
      with hyperlipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants with the diagnosis of hyperlipidemia and receiving instructions for
             lifestyle improvement

          2. Participants with a fasting TG level of 150 -499 mg/dL at Visit 1 after informed
             consent (Day -29 to Day -1 before start of study drug administration)

          3. Participants receiving a stable dose of HMG-CoA reductase inhibitor therapy
             continuously for at least 4 weeks before informed consent at Visit 1 (Day -29 to Day
             -1 before start of study drug administration)

          4. Male or postmenopausal female participants

          5. Participants who, in the opinion of the principal investigator or the investigator,
             are capable of understanding the content of the clinical research and complying with
             the research protocol requirements.

          6. Participants who can provide written informed consent prior to the conduction of the
             clinical research procedures

          7. Participants aged ≥20 years at the time of informed consent at Visit 1(Day -28 to Day
             0 before the start of study drug administration)

        Exclusion Criteria:

          1. Participants with a history of revascularization or those have had coronary artery
             disease (a definitive diagnosis of myocardial infarction, angina) within 24 weeks
             before informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug
             administration)

          2. Participants who have undergo aortic aneurysmectomy within 24 weeks prior to informed
             consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)
             or those with concurrent aortic aneurysm

          3. Participants who have had clinically significant hemorrhagic disorders (e.g.,
             hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage,
             hemoptysis, and vitreous hemorrhage) within 24 weeks prior to informed consent at
             Visit 1 (Day -29 to Day -1 before the start of study drug administration) or those who
             concurrently have the above disorders

          4. Participant with a fasting FMD level of 0% measured at the start of study drug
             administration at Visit 2 (Day -15 to Day -1 before the start of study drug
             administration)

          5. Participants in whom the type and dosage of HMG-CoA reductase inhibitors, antidiabetic
             drugs and antihypertensive drugs have been changed within 4 weeks prior to informed
             consent at Visit 1 (Day -29 to Day -1 before the start of study drug administration)

          6. Participants who have started anti dyslipidemic agents within 4 weeks prior to
             informed consent at Visit 1 (Day -29 to Day -1 before the start of study drug
             administration)

          7. Participants requiring a change in the dose of dyslipidemia therapeutic, antidiabetic,
             or antihypertensive drugs during the period between informed consent at Visit 1 (Day
             -29 to Day -1 before the start of study drug administration) and the start of study
             drug administration at Visit 2 (Day -15 to Day -1 before the start of study drug
             administration)

          8. Participants with severe hepatic dysfunction

          9. Participants with severe renal dysfunction (as an indicator, CKD category ≥G3b,
             equivalent to an A3)

         10. Participants who have been diagnosed with pancreatitis

         11. Participants who have been diagnosed with lipoprotein lipase deficiency, apoprotein
             C-II deficiency, familial hypercholesterolemia, familial combined hyperlipidemia, or
             familial type III hyperlipidemia

         12. Participants with concurrent Cushing's syndrome, uremia, systemic lupus erythematosus
             (SLE), serum dysproteinemia, or hypothyroidism

         13. Participants with symptomatic Peripheral Arterial Disease (PAD)

         14. Participants with concurrent hypertension of grade II or higher Note 1) Note 1:
             Participants with systolic blood pressure of ≥160 mm Hg or diastolic BP of ≥100 mm Hg
             regardless of treatment with antihypertensive drugs

         15. Participants who are habitual drinkers drinking an average of over 100 mL per day
             (expressed in terms of quantity of alcohol) or participants with, or with a history of
             drug abuse or addiction Note 2)

         16. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl
             esters-

         17. Participants who smoke

         18. Participants participating in other clinical studies

         19. Participants who have been determined to be ineligible as subjects in the study by the
             principal investigator or the investigator