At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase
In Brief
A Phase 2 clinical trial evaluating alirocumab SAR236553 (REGN727), statins, and 5 other interventions for Hypercholesterolaemia. Completed, enrolled 42 participants across 16 sites in 10 countries.
Detailed Summary
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre \[mmol/L\]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period. Secondary Objective: * To evaluate the safety and tolerability of alirocumab. * To evaluate the pharmacokinetics profile of alirocumab. * To evaluate the effects of alirocumab on other lipid parameters.
Study Details
Timeline
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous injection
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form:tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral