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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT01166633
Eligibility Criteria:
Inclusion Criteria:
* Patients aged between 25 and 75
* Patients who signed informed consent forms of their own volition;
* Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
* Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal
Exclusion Criteria:
* Patients with uncompensated liver cirrhosis.
* Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
* Patients who had taken antiviral drugs for viral hepatitis.
* Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
* Patients whose triglyceride(TG) levels were 400mg/dL or higher.
* Patients with uncontrolled hypertension (DBP≧100mmHg)
* Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
* Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
* Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
* Female patients who were nursing or being pregnant or were planning on becoming pregnant.
* Patients judged to be unsuitable by investigators.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT01166633
Study Brief:
Protocol Section:
NCT01166633