An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT03510884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2023-05-06
Summary
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.
Conditions
- Hypercholesterolaemia
Interventions
- DRUG
-
Alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution Route of administration: subcutaneous injection
- DRUG
-
Rosuvastatin
Pharmaceutical form:tablet Route of administration: oral
- DRUG
-
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Simvastatin
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Pravastatin
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Lovastatin
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Fluvastatin
Pharmaceutical form:Capsule Route of administration: Oral
- DRUG
-
Ezetimibe
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Cholestyramine
Pharmaceutical form:oral suspension Route of administration: oral
- DRUG
-
Nicotinic acid
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Fenofibrate
Pharmaceutical form:Tablet Route of administration: Oral
- DRUG
-
Omega-3 fatty acids
Pharmaceutical form:capsule Route of administration: oral
- DRUG
-
Pharmaceutical form:solution Route of administration: subcutaneous injection
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 8 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-31
- Primary Completion
- 2021-01-14
- Completion
- 2022-08-05
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Austria
- Brazil
- Bulgaria
- Canada
- Czechia
- Denmark
- Finland
- France
- Hungary
- Italy
- Lebanon
- Mexico
- Netherlands
- Norway
- Poland
- Russia
- Slovenia
- South Africa
- Spain
- Sweden
- Taiwan
- Turkey (Türkiye)
Study Locations
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