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NCT01926782 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
A Phase 3 study of Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 803
- Enrollment target
- 20
- Study locations
NCT01926782: Completed Phase 3 study of Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals.
NCT01926782 is a Phase 3 study of Hypercholesterolemia that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 803 participants, roughly in line with the 804-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01926782, a Phase 3 study of Hypercholesterolemia, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 803 participants
- Enrollment target
- 20
- Study locations
Study Summary
To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
Primary Outcome
Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comp
Conditions Studied
Interventions
- DRUG Statin
- DRUG Alirocumab
- DRUG Placebo (for alirocumab)
Study Locations (20)
California
- - Carmichael
- - Fresno
- - West Hills
- - Wildomar
Florida
- - Boynton Beach
- - Jacksonville
- - Safety Harbor
Arizona
- - Chandler
- - Goodyear
Colorado
- - Colorado Springs
- - Golden
Idaho
- - Boise
- - Meridian
Illinois
- - Chicago
- - Gurnee
Indiana
- - Evansville
- - Indianapolis
Georgia
- - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 803 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01926782 record still lists
NCT01926782 is an interventional study that assigns participants to a tested intervention. The registered 803 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 804-participant average among 62 other Hypercholesterolemia trials with a reported enrollment target.
The record links to 1 condition, with Hypercholesterolemia appearing as the primary indexed condition, and to 3 interventions - of which Statin is the first listed.
NCT01926782 names 20 study sites across 10 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT01926782 about?
NCT01926782 is a clinical study titled "Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)". To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.
What is the current status of trial NCT01926782?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 803 participants. The study started on 2013-09. Estimated completion is 2015-04.
What conditions does trial NCT01926782 study?
This clinical trial studies the following conditions: Hypercholesterolemia.
What interventions are being tested in trial NCT01926782?
The interventions under investigation include: Statin (DRUG), Alirocumab (DRUG), Placebo (for alirocumab) (DRUG).
Who is sponsoring clinical trial NCT01926782?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01926782 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypercholesterolemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01926782's enrollment target sits among peer trials
803 15th of 62 higher than 48 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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