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NCT01644474 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
NCT01644474 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 103 participants.
The verdict
NCT01644474, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
Study Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points * To evaluate the effect of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab
Interventions
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Placebo (for Alirocumab)
- DRUG Placebo (for Ezetimibe)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2012-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01644474
The ClinicalTrials.gov registry entry for NCT01644474 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 103 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 4 interventions - of which Ezetimibe is the first listed.
NCT01644474 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01644474 about?
NCT01644474 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 week...
What is the current status of trial NCT01644474?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2012-07. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01644474?
The interventions under investigation include: Ezetimibe (DRUG), Alirocumab (DRUG), Placebo (for Alirocumab) (DRUG), Placebo (for Ezetimibe) (DRUG).
Who is sponsoring clinical trial NCT01644474?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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