Overview

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Status:
Completed

Trial end date:
2019-02-22

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Cholestyramine Resin
Ezetimibe
Fenofibrate
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Niacin
Niacinamide
Nicotinic Acids