NCT01926782

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 803 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Placebo (for alirocumab)	Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
DRUG	Alirocumab	Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
DRUG	Statin	Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-09-01
• Completion: 2015-04-01
• First posted: 2013-08-21
• Last updated: 2017-03-21
• Results posted: 2017-03-21

Locations

83 sites across 8 countries: United States, Bulgaria, Canada, Hungary, Israel, Norway, Slovakia, United Kingdom