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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT01109368
Eligibility Criteria:
Inclusion criteria:
1\. Patients of any age and sex who meet clinical or genetic criteria for hoFH as follows:
* Documented, untreated fasting LDL cholesterol level of \> 500 mg/dL and triglycerides \< 200 mg/dL on a cholesterol-lowering diet for at least 8 weeks with secondary causes excluded, AND:
* DNA confirmation of a double mutation of the LDL receptor or apoB gene OR
* LDL \> 160 mg/dL in both biological parents not associated with a disorder know to elevate LDL OR
* Coronary artery disease in one or both parents or grandparents \< 55 years for males, \< 65 for females OR
* Tendinous/cutaneous xanthomas \< age 10 or coronary artery disease \< age 20
Exclusion criteria:
1\. Inability of patient, or, if less than 18, a parent, to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01109368
Study Brief:
Protocol Section:
NCT01109368