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NCT01507831 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
A Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,341
- Enrollment target
- 20
- Study locations
NCT01507831: Completed Phase 3 study of Hypercholesterolemia, sponsored by Sanofi.
NCT01507831 is a Phase 3 study of Hypercholesterolemia that has completed, run by Sanofi. The registered enrollment target is 2,341 participants, above the 779-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (201% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01507831, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,341 participants
- Enrollment target
- 20
- Study locations
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 long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: * To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. * 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.
Primary Outcome
Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).
Conditions Studied
Interventions
- DRUG Alirocumab
- DRUG Lipid-Modifying Therapy (LMT)
- DRUG Placebo (for alirocumab)
Study Locations (20)
California
- Investigational Site Number 840209 - Beverly Hills
- Investigational Site Number 840194 - Beverly Hills
- Investigational Site Number 840207 - Fresno
- Investigational Site Number 840101 - Lincoln
- Investigational Site Number 840076 - Long Beach
- Investigational Site Number 840214 - Pasadena
- Investigational Site Number 840045 - Sacramento
- Investigational Site Number 840163 - Santa Rosa
Arizona
- Investigational Site Number 840028 - Gilbert
- Investigational Site Number 840035 - Sierra Vista
- Investigational Site Number 840052 - Tempe
- Investigational Site Number 840065 - Tempe
- Investigational Site Number 840079 - Tempe
- Investigational Site Number 840094 - Tempe
- Investigational Site Number 840103 - Tucson
Colorado
- Investigational Site Number 840086 - Colorado Springs
- Investigational Site Number 840077 - Golden
Connecticut
- Investigational Site Number 840224 - Bridgeport
- Investigational Site Number 840134 - Guilford
Alabama
- Investigational Site Number 840159 - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,341 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-11 |
| Phase | Phase 3 |
What the finished NCT01507831 record still lists
NCT01507831 is an interventional study that assigns participants to a tested intervention. Its 2,341 participants enrollment target places it among the larger protocols in the corpus, above the 779-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (201% higher).
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.
NCT01507831 names 20 study sites across 5 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT01507831 about?
NCT01507831 is a clinical study titled "Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)". 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 long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia n...
What is the current status of trial NCT01507831?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,341 participants. The study started on 2012-01. Estimated completion is 2014-11.
What conditions does trial NCT01507831 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01507831?
The interventions under investigation include: Alirocumab (DRUG), Lipid-Modifying Therapy (LMT) (DRUG), Placebo (for alirocumab) (DRUG).
Who is sponsoring clinical trial NCT01507831?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01507831 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01507831's enrollment target sits among peer trials
2,341 4th of 62 higher than 59 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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