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NCT01623115 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 486
- Enrollment target
NCT01623115: Completed Phase 3 study, sponsored by Sanofi.
NCT01623115 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 486 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01623115, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 486 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 evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points * To evaluate the effects 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 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
Interventions
- DRUG Alirocumab
- DRUG Placebo (for alirocumab)
- DRUG Lipid Modifying Therapy (LMT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01623115 record still lists
NCT01623115 is an interventional study that assigns participants to a tested intervention. The registered 486 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 (37% lower).
The record links to 0 conditions, and to 3 interventions - of which Alirocumab is the first listed.
NCT01623115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01623115 about?
NCT01623115 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison...
What is the current status of trial NCT01623115?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 486 participants. The study started on 2012-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01623115?
The interventions under investigation include: Alirocumab (DRUG), Placebo (for alirocumab) (DRUG), Lipid Modifying Therapy (LMT) (DRUG).
Who is sponsoring clinical trial NCT01623115?
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 NCT01623115's enrollment target sits among peer trials
486 789th of 2000 higher than 1,211 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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