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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02208869
Eligibility Criteria:
Inclusion Criteria:
* Total cholesterol ≥7.5 mmol/L or LDL-C ≥4.9 mmol/L (pretreatment levels)
* Familial hypercholesterolemia defined as: a. Mutation in the LDL receptor and/or the ApoB gene and/or the PCSK9 gene; or b. clinical diagnosis of heterozygous FH (HeFH) according to the Dutch Lipid Network Criteria or Simon Broom Criteria
* Patients with genetic mutation of FH
Exclusion Criteria:
* uncontrolled primary hypothyroidism (thyroid stimulating hormone (TSH) \>1.5 x upper limit of normal (ULN)),
* nephrotic syndrome and/or renal dysfunction (scrum creatinine \>2.0 mg/dL or 160mmol/l, creatinine clearance \<15 ml/min) at screening.
* uncontrolled diabetes mellitus (Glycated hemoglobin \>8.5%)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
80 Years
Study:
NCT02208869
Study Brief:
Protocol Section:
NCT02208869