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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01507831
The ClinicalTrials.gov registry entry for NCT01507831 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,341 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 779-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target (201% higher). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.