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:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02285166
Eligibility Criteria:
Inclusion Criteria:
Participants who meet all of the following criteria will be included in the survey:
1. Patients with hyperlipidemia on statin therapy
2. Outpatients
3. Male participants aged ≥ 50 years and female participants aged ≥ 60 years
4. Participants with fasting TG level ≥ 150 mg/dL (within 3 months prior to the start of the observation period)
5. Participants who have at least two of the following risk factors:
* Hypertension
* Type 2 diabetes mellitus
* Chronic kidney disease
* Prior history of myocardial infarction or angina pectoris
* Prior history of cerebral infarction
* Peripheral arterial disease
Exclusion Criteria:
-Participants who meet any of the following criteria will be excluded from the survey:
1. Participants who have experienced coronary artery disease within 1 month prior to the start of the observation period
2. Participants who have experienced cerebrovascular disease within 1 month prior to the start of the observation period
3. Participants who have undergone heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention) within 1 month prior to the start of the observation period
4. Participants who plan to undergo heart surgery or revascularization surgery (including coronary artery intervention and peripheral arterial intervention)
5. Patients with malignant tumors currently under treatment
6. Participants who have received eicosapentaenoic acid (hereinafter, EPA) products within 1 month prior to the start of the observation period, or participants who plan to receive treatment with EPA products after the start of the observation period
7. Patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage)
8. Participants with prior history of hypersensitivity to any ingredients in omega-3 fatty acid ethyl esters (omega-3 fatty acid ethyl esters-treated participants only)
9. Participants with prior history of treatment with omega-3 fatty acid ethyl esters
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02285166
Study Brief:
Protocol Section:
NCT02285166