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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT01375751
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 75 years of age
* Diagnosis of heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991)
* On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
* Fasting Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 100 mg/dL
* Fasting triglycerides ≤ 400 mg/dL
Exclusion Criteria:
* Homozygous familial hypercholesterolemia
* Low-Density Lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization
* New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction \< 30%
* Uncontrolled cardiac arrhythmia
* Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
* Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
* Uncontrolled hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01375751
Study Brief:
Protocol Section:
NCT01375751