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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT00398294
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient, \>18 years of age
* Patients with hypercholesterolemia who meet the following lipid criteria:
1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl
2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl
* The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study
Exclusion Criteria:
* Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmias, unstable angina pectoris
* Myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1
* Uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1.
* Unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00398294
Study Brief:
Protocol Section:
NCT00398294