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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 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 233 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02023879
The ClinicalTrials.gov registry entry for NCT02023879 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 233 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Alirocumab is the first listed.
NCT02023879 reports 0 study locations.
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.
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