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NCT01730040 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 355
- Enrollment target
NCT01730040: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT01730040 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 355 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01730040, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 355 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
Primary Outcome
Calculated LDL-C values were obtained from Friedewald formula. 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 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Interventions
- DRUG Placebo
- DRUG Rosuvastatin
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01730040 record still lists
NCT01730040 is an interventional study that assigns participants to a tested intervention. The registered 355 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 (54% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01730040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01730040 about?
NCT01730040 is a clinical study titled "Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)". This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
What is the current status of trial NCT01730040?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 355 participants. The study started on 2012-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01730040?
The interventions under investigation include: Placebo (DRUG), Rosuvastatin (DRUG), Ezetimibe (DRUG), Alirocumab (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01730040?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01730040's enrollment target sits among peer trials
355 1025th of 2000 higher than 975 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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