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NCT01644175 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
A Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 316
- Enrollment target
- 20
- Study locations
NCT01644175: Completed Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
NCT01644175 is a Phase 3 study of Hypercholesterolemia that has completed, run by Sanofi. The registered enrollment target is 316 participants, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01644175, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 316 participants
- Enrollment target
- 20
- Study locations
Study Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: * To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo 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 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
Conditions Studied
Interventions
- DRUG Alirocumab
- DRUG Lipid-Modifying Therapy (LMT)
- DRUG Placebo (for alirocumab)
Study Locations (20)
California
- Investigational Site Number 840870 - Burbank
- Investigational Site Number 840851 - Los Angeles
- Investigational Site Number 840845 - Los Gatos
- Investigational Site Number 840844 - Sacramento
- Investigational Site Number 840801 - San Jose
- Investigational Site Number 840886 - Tarzana
- Investigational Site Number 840862 - Torrance
- Investigational Site Number 840893 - Vista
Florida
- Investigational Site Number 840867 - Boca Raton
- Investigational Site Number 840884 - Boynton Beach
- Investigational Site Number 840836 - Clearwater
- Investigational Site Number 840866 - Coral Gables
- Investigational Site Number 840895 - Fort Lauderdale
- Investigational Site Number 840820 - Hialeah
- Investigational Site Number 840805 - Miami
Alabama
- Investigational Site Number 840857 - Birmingham
- Investigational Site Number 840891 - Mobile
- Investigational Site Number 840876 - Montgomery
Arizona
- Investigational Site Number 840865 - Glendale
Arkansas
- Investigational Site Number 840826 - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01644175 record still lists
NCT01644175 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 812-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 3 interventions - of which Alirocumab is the first listed.
NCT01644175 names 20 study sites across 5 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01644175 about?
NCT01644175 is a clinical study titled "Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)". Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: * To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally to...
What is the current status of trial NCT01644175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 316 participants. The study started on 2012-07. Estimated completion is 2014-04.
What conditions does trial NCT01644175 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01644175?
The interventions under investigation include: Alirocumab (DRUG), Lipid-Modifying Therapy (LMT) (DRUG), Placebo (for alirocumab) (DRUG).
Who is sponsoring clinical trial NCT01644175?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01644175 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01644175's enrollment target sits among peer trials
316 25th of 62 higher than 38 of 62 other Hypercholesterolemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypercholesterolemia 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.
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