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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT00438893
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult men and postmenopausal women currently enrolled in the long-term portfolio study
* Body mass index \<32 kg/m2
* Constant body weight over last 6 months preceding the onset of the study
* Fasting LDL-cholesterol concentration \>4.1 mmol/L at diagnosis
Exclusion Criteria:
* women of child-bearing potential
* major cardiovascular event (stroke or myocardial infarction)
* positive molecular diagnosis of familial hypercholesterolemia
* secondary causes of hypercholesterolemia (hypothyroidism, unless treated \& on a stable dose of L-thyroxine, renal or liver disease)
* use of cholesterol-lowering medications
* serum triglycerides \>4.5 mmol/L
* blood pressure \> 145/90 mmHg
* diabetes and/or major disorders such as liver disease, renal failure or cancer
* major surgery \<6 months prior to randomization
* alcohol consumption \>2 drinks per day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00438893
Study Brief:
Protocol Section:
NCT00438893