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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 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 42 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02890992
The ClinicalTrials.gov registry entry for NCT02890992 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 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 fenofibrate is the first listed.
NCT02890992 reports 0 study locations.
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.
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