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 @ 3:38 PM
Ignite Modification Date:
2025-12-24 @ 3:38 PM
NCT ID:
NCT02890992
Eligibility Criteria:
Inclusion criteria :
* Children and adolescent male and female participants aged of 8 to 17 years at the time of signed informed consent. For Russia only: Male and female participants aged \>=12 and \<=17 years at the time of signed informed consent.
* Participants with diagnosis of heterozygous familial hypercholesterolemia (heFH) through genotyping or clinical criteria.
* Participants treated with optimal dose of statin +/- other LMT(s) or non-statin LMT(s) if statin intolerant at stable dose for at least 4 weeks prior to screening lipid sampling.
* Participants with calculated LDL-C greater than or equal to 130 mg/dL (\>=3.37 mmol/L) at the screening visit.
* Participants with body weight greater than or equal to 25 kg.
* Participants aged of 8 to 9 years to be at Tanner stage 1 and participants aged of 10 to 17 years to be at least at Tanner stage 2 in their development.
* A signed informed consent indicating parental permission with or without participant assent.
Exclusion criteria:
* Participant with secondary hyperlipidemia.
* Diagnosis of homozygous familial hypercholesterolemia.
* Participant who had received lipid apheresis treatment within 2 months prior to the screening period, or has plans to receive it during the study.
* Known history of type 1 or type 2 diabetes mellitus.
* Known history of thyroid disease.
* Known history of hypertension.
* Fasting triglycerides \>350 mg/dL (3.95 mmol/L).
* Severe renal impairment (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m\^2).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 x upper limit of normal (ULN).
* Creatinine phosphokinase (CPK) \>3 x ULN.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT02890992
Study Brief:
Protocol Section:
NCT02890992