An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

About the trial

Sponsor

Sanofi (with Regeneron Pharmaceuticals)

Tested

Alirocumab SAR236553 (REGN727) (drug), Rosuvastatin (drug), Atorvastatin (drug), Simvastatin (drug), Pravastatin (drug), Lovastatin (drug), Fluvastatin (drug), Ezetimibe (drug), Cholestyramine (drug), Nicotinic acid (drug), Fenofibrate (drug), Omega-3 fatty acids (drug), Placebo (drug)

Dates

Started 2018-05-31; completion 2022-08-05

Results posted

Yes

Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age 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. Secondary Objectives: * To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. * To evaluate the effects of alirocumab versus placebo on other lipid parameters. * To evaluate the safety and tolerabili…

From ClinicalTrials.gov, last updated 2023-05-06. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $4,578 in research payments for this study in 2025 (1 payments).

Products named: Praluent

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.