Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: TAK-085; Not treated with omega-3-acid ethyl esters
Intervention description: Omega-3-acid ethyl esters (TAK-085) capsule; Not treated with omega-3-acid ethyl esters
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid
      ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients
      receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group
      of patients not treated with omega-3-acid ethyl esters.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants diagnosed as hyperlipidemia.

          2. Participants constantly receiving a HMG-CoA reductase inhibitor at a stable dose for
             at least 4 weeks at the start of the observation period.

          3. Participants with fasting TG of 150≤ to <400 mg/dL measured at the start of the
             observation period at Visit 1 (Week -4).

          4. Participants who, in the opinion of the principal investigator or the investigator,
             are capable of understanding the content of the clinical study and complying with the
             study protocol requirements.

          5. Participants who can provide written informed consent prior to the conduction of the
             clinical study procedures.

          6. Participants aged ≥20 years at the time of informed consent at Visit 1 (Week -4).

        Exclusion Criteria:

          1. Participants who had clinically significant hemorrhagic disorders (e.g., hemophilia,
             capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, and
             vitreous hemorrhage) within 24 weeks prior to the start of the observation period, or
             those who concurrently have the above disorders.

          2. Participants who had thyroid disorders (hyperthyroidism or hypothyroidism) within 24
             weeks prior to the start of the observation period, those who concurrently have the
             above disorders, or those who are orally receiving a therapeutic drug for thyroid
             disorder.

          3. Participants in whom the type of HMG-CoA reductase inhibitors was changed within 12
             weeks prior to the start of observation period.

          4. Participants who received an eicosapentaenoic acid (EPA) preparation or an
             EPA/docosahexaenoic acid (DHA) preparation (including supplements) within 12 weeks
             prior to the start of observation period.

          5. Participants who started antidyslipidemic agents within 4 weeks prior to the start of
             observation period.

          6. Participants with severe hepatic impairment (e.g., Child-Pugh classification C).

          7. Participants who were previously diagnosed as lipoprotein lipase deficiency or
             apoprotein C-II deficiency.

          8. Participants who are concurrently having Cushing's syndrome, uremia, systemic lupus
             erythematosus (SLE), or serum dysproteinemia.

          9. Diabetic participants who are currently receiving thiazolidine or insulin.

         10. Participants who are concurrently having hypertension of grade IIINote 1). Note 1:
             Participants with systolic blood pressure of ≥180 mm Hg or diastolic blood pressure of
             ≥110 mm Hg regardless of treatment with antihypertensive drugs.

         11. 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.

         12. Pregnant, lactating or postmenopausal women.

         13. Participants with a history of hypersensitivity or allergy for omega-3-acid ethyl
             esters.

         14. Participants participating in other clinical studies.

         15. Participants assessed ineligible in the study by the principal investigator or the
             investigator.