Completed PHASE3 INTERVENTIONAL 7-arm NCT01730040

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

Sponsor: Regeneron Pharmaceuticals

Conditions Hypercholesterolemia

Interventions Alirocumab Atorvastatin Ezetimibe Placebo Rosuvastatin

Updated 7 times since 2017 Last updated: Jul 29, 2015 Started: Oct 31, 2012 Primary completion: Apr 30, 2014 Completion: May 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Hypercholesterolemia and is currently completed. Regeneron Pharmaceuticals leads this study, which shows 7 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Oct 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Regeneron Pharmaceuticals
Sanofi

Data source: Regeneron Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Atlantis, United States , Auburn, United States , Bad Oeynhausen, Germany , Barcelona (3 Locations), Spain , Berlin, Germany , Bethesda, United States , Beverly Hills, United States , Boca Raton, United States , Boise, United States and 87 more locations