Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT02839902
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02839902
Study Brief:
Protocol Section:
NCT02839902