An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Public ClinicalTrials.gov record NCT03510884. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study Followed by an Open Label Treatment Period to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03510884
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 8 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 30, 2018
- Primary completion
- Jan 13, 2021
- Completion
- Aug 4, 2022
- Last update posted
- May 5, 2023
2018 – 2022
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Excel Medical Clinical Trials, LLC-Site Number:8400001 | Boca Raton | Florida | 33434 | — |
| Washington University School of Medicine-Site Number:8400006 | St Louis | Missouri | 63110 | — |
| Presbyterian Novant Heart & Wellness-Site Number:8400002 | Charlotte | North Carolina | 28204 | — |
| Cincinnati Children's Hospital Medical Center-Site Number:8400005 | Cincinnati | Ohio | 45229 | — |
| Vanderbilt University-Site Number:8400003 | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03510884, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03510884 live on ClinicalTrials.gov.