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NCT02890992 · ClinicalTrials.gov registry record · Phase 2
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02890992: Completed Phase 2 study, sponsored by Sanofi.
NCT02890992 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02890992, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre \[mmol/L\]) 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. Secondary Objective: * To evaluate the safety and tolerability of alirocumab. * To evaluate the pharmacokinetics profile of alirocumab. * To evaluate the effects of alirocumab on other lipid parameters.
Primary Outcome
Percent change in calculated LDL-C was defined as 100\*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period \& within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 day
Interventions
- DRUG fenofibrate
- DRUG ezetimibe
- DRUG alirocumab SAR236553 (REGN727)
- DRUG statins
- DRUG cholestyramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2016-09-15 |
| Est. Completion | 2019-02-22 |
| Phase | Phase 2 |
What the finished NCT02890992 record still lists
NCT02890992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which fenofibrate is the first listed.
NCT02890992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02890992 about?
NCT02890992 is a clinical study titled "An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia". Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C \>=130 milligrams per deciliter (mg/dL) (3.37 millimoles per l...
What is the current status of trial NCT02890992?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2016-09-15. Estimated completion is 2019-02-22.
What interventions are being tested in trial NCT02890992?
The interventions under investigation include: fenofibrate (DRUG), ezetimibe (DRUG), alirocumab SAR236553 (REGN727) (DRUG), statins (DRUG), cholestyramine (DRUG).
Who is sponsoring clinical trial NCT02890992?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02890992's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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