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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01763918
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 80 years of age
* Diagnosis of heterozygous familial hypercholesterolemia
* On a stable dose of an approved statin and lipid regulating medication
* Fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L)
* Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)
Exclusion Criteria:
* Homozygous familial hypercholesterolemia
* LDL or plasma apheresis
* New York Heart Association (NYHA) III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes, poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01763918
Study Brief:
Protocol Section:
NCT01763918