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NCT01709513 · ClinicalTrials.gov registry record · Phase 3
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
A Phase 3 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT01709513 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 314 participants.
The verdict
NCT01709513, a Phase 3 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.
Interventions
- DRUG Placebo
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Atorvastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2012-09-30 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709513
The ClinicalTrials.gov registry entry for NCT01709513 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01709513 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01709513 about?
NCT01709513 is a clinical study titled "Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)". This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins...
What is the current status of trial NCT01709513?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2012-09-30. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT01709513?
The interventions under investigation include: Placebo (DRUG), Ezetimibe (DRUG), Alirocumab (DRUG), Atorvastatin (DRUG).
Who is sponsoring clinical trial NCT01709513?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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