Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Regeneron Pharmaceuticals.
NCT01709513 is a Phase 3 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
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 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 |
What the finished NCT01709513 record still lists
NCT01709513 is an interventional study that assigns participants to a tested intervention. The registered 314 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 (59% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01709513 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01709513's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03866382 · 314 participants · Phase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
- NCT04500756 · 314 participants · Phase 2
Limiting AAA With Metformin (LIMIT) Trial
- NCT06167746 · 314 participants · Phase 3
iCare4Me Transitions
- NCT06883097 · 314 participants · NA
Quitting Matters Human Immunodeficiency Virus Hybrid Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI