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NCT02023879 · ClinicalTrials.gov registry record · Phase 3
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT02023879: Completed Phase 3 study, sponsored by Sanofi.
NCT02023879 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 233 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02023879, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: * To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. * To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.
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 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Interventions
- DRUG Alirocumab
- DRUG Placebo (for Alirocumab)
- DRUG Non-statin LMT
- OTHER Diet Alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 3 |
What the finished NCT02023879 record still lists
NCT02023879 is an interventional study that assigns participants to a tested intervention. The registered 233 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 (70% lower).
The record links to 0 conditions, and to 4 interventions - of which Alirocumab is the first listed.
NCT02023879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02023879 about?
NCT02023879 is a clinical study titled "Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)". Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants w...
What is the current status of trial NCT02023879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2013-12-16. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT02023879?
The interventions under investigation include: Alirocumab (DRUG), Placebo (for Alirocumab) (DRUG), Non-statin LMT (DRUG), Diet Alone (OTHER).
Who is sponsoring clinical trial NCT02023879?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02023879's enrollment target sits among peer trials
233 1298th of 2000 higher than 703 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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