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NCT03510884 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 153
- Enrollment target
NCT03510884 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 153 participants.
The verdict
NCT03510884, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 153 participants
- Enrollment target
Study 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.
Interventions
- DRUG Rosuvastatin
- DRUG Simvastatin
- DRUG Atorvastatin
- DRUG Pravastatin
- DRUG Alirocumab SAR236553 (REGN727)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2022-08-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03510884
The ClinicalTrials.gov registry entry for NCT03510884 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Rosuvastatin is the first listed.
NCT03510884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03510884 about?
NCT03510884 is a clinical study titled "An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia". 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...
What is the current status of trial NCT03510884?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2018-05-31. Estimated completion is 2022-08-05.
What interventions are being tested in trial NCT03510884?
The interventions under investigation include: Rosuvastatin (DRUG), Simvastatin (DRUG), Atorvastatin (DRUG), Pravastatin (DRUG), Alirocumab SAR236553 (REGN727) (DRUG).
Who is sponsoring clinical trial NCT03510884?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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