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Sponsor: Sanofi
Conditions: Hypercholesterolaemia
Interventions: Alirocumab SAR236553 (REGN727), Rosuvastatin, Atorvastatin, Simvastatin, Pravastatin
Countries: United States, Argentina, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark
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 tolerability of alirocumab in comparison with placebo. * To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. * To evaluate the development of anti-alirocumab antibodies.
Sex: ALL
Age: 8 Years to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion criteria: * Children and adolescent male and female participants 8 to 17 years of age at the time of signed informed consent. * Participants with diagnosis of 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 except for participants who have previously participated in the DFI14223 (NCT02890992) study. * A signed informed consent indicating parental permission with or without participant assent. Exclusion criteria: * Participant with body weight \< 25 kg. * Participants aged of 8 to 9 years not at Tanner stage 1 and participants aged of 10 to 17 years not at least at Tanner stage 2 in their development. * Participants 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. * Participants with uncontrolled type 1 or type 2 diabetes mellitus. * Participants with known uncontrolled thyroid disease. * Participants with uncontrolled hypertension. * Fasting triglycerides greater than (\>) 350 mg/dL (3.95 mmol/L). * Severe renal impairment (ie, estimated glomerular filtration rate \<30 mL/min/1.73 m\^2). * Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal (ULN). * Creatinine phosphokinase (CPK) \>3\*ULN. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
- Boca Raton, Florida, United States
- St Louis, Missouri, United States
- Charlotte, North Carolina, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Buenos Aires, Argentina
- Vienna, Austria
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, Brazil
- Plovdiv, Bulgaria
- Québec, Canada
- Brno, Czechia
- Praha 5 - Motol, Czechia
- Copenhagen, Denmark
- HUS, Finland
- Bron, France
- Nantes, France
- Budapest, Hungary
- Milan, Italy
- Palermo, Italy
- Roma, Italy
- Beirut, Lebanon
- Room Hospital Street, Achrafie, Lebanon
- Guadalajara, Jalisco, Mexico
- Oaxaca City, Mexico
- Amsterdam, Netherlands
- Oslo, Norway
- Gdansk, Pomeranian Voivodeship, Poland
- Lodz, Poland
- Kazan', Russia
- + 13 more on CT.gov