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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01587235
Eligibility Criteria:
Inclusion Criteria:
* Low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL
* Either treatment naïve (no previous treatment with lipid-lowering medication) or if previously treated with lipid-lowering medication, must complete a wash-out 6 weeks prior to enrollment
Exclusion Criteria:
* LDL-C level ≥ 190 mg/dL
* Hypersensitivity or intolerance to Vytorin, ezetimibe or simvastatin
* Taking other lipid lowering agent except statins. (i.e. fenofibrate, niacin, ezetimibe, etc)
* Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
* Currently participating in or has previously participated in a study within 30 days
* Congestive heart failure defined by New York Heart Association (NYHA) Class III or IV within previous 6 months
* Uncontrolled cardiac arrhythmias or recent significant electrocardiogram (ECG) changes
* Unstable angina pectoris
* Myocardial infarction, coronary artery bypass surgery, or angioplasty within previous 3 months
* Unstable or severe peripheral artery disease within previous 3 months
* Uncontrolled hypertension (treated or untreated)
* Type 1 or Type 2 diabetes mellitus that is poorly controlled or recently diagnosed (within previous 3 months)
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Serious cerebrovascular disorder (ischemic stroke or cerebral hemorrhage) within the previous 6 months
* Received treatment with systemic corticosteroids, any cyclical hormones
within previous 8 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01587235
Study Brief:
Protocol Section:
NCT01587235