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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT00129402
Eligibility Criteria:
Inclusion Criteria:
* Adolescent (ages 10 - 17 years) boys or girls weighing at least 88 lbs (40 kg).
* Subjects must have high cholesterol (low density lipoprotein cholesterol \[LDL-C\] more than 159 mg/dL or 4.1 mmol/L) and a family history of high cholesterol.
Exclusion Criteria:
* Subjects diagnosed with delayed puberty.
* Subjects who are sensitive to simvastatin and/or ezetimibe.
* Subjects who drink alcohol excessively or who have a history of alcohol or drug abuse within the past 2 years.
* Subjects who are known to be HIV positive, are undergoing LDL apheresis or plasma apheresis, or have had a partial ileal bypass.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT00129402
Study Brief:
Protocol Section:
NCT00129402