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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: Completed Phase 3 study, sponsored by Sanofi.
NCT01644474 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 103 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
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 |
What the finished NCT01644474 record still lists
NCT01644474 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 4 interventions - of which Ezetimibe is the first listed.
NCT01644474 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01644474's enrollment target sits among peer trials
103 1674th of 2000 higher than 325 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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