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:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-26 @ 10:59 AM
NCT ID:
NCT02205606
Eligibility Criteria:
Inclusion Criteria:
* Aged over 19 years
* Signed informed consent
* At visit 1, LDL-C ≤ 250mg/dL and Triglyceride \< 400 mg/dL
* After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride \< 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease
Exclusion Criteria:
* Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
* Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
* Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
* CK level exceeds more than 5 times of normal upper limit
* Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
* Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
* Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02205606
Study Brief:
Protocol Section:
NCT02205606