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

Registry ID

EUCTR2015-003766-85

Source registry

EUCTR

Status

Completed

Phase

PHASE2

Sponsor

sanofi-aventis recherche&developpement

Start date

2016-07-29

Completion date

2019-02-22

Last update

2026-08-16

Conditions

• Hypercholesterolaemia

Summary

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) patients age of 8 to 17 years, with LDL-C ≥130 mg/dL (3.37 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.

Locations

• , , France
• , , Spain
• , , Czechia
• , , Sweden

Related clinical trials

• A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
• A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias
• An Efficacy and Safety Study of Akkermansia Muciniphila AKM Lab-01 in Hypercholesterolaemia
• Phase 3 Clinical Study Evaluating Efficacy, Safety, and Tolerability of Obicetrapib Vs Bempedoic Acid to Treat Dyslipidemia in Adults With Primary Non-familial Hypercholesterolemia or Mixed Dyslipidemia at High to Very High Cardiovascular Risk, During a Treatment Period of Approximately 84 Days
• Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in Italy
• LATAM LOWERS LDL-C

View on source registry