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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Alirocumab	Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
DRUG	Atorvastatin	Atorvastatin over-encapsulated tablets orally.
DRUG	Ezetimibe	Ezetimibe over-encapsulated tablet orally.
DRUG	Rosuvastatin	Rosuvastatin over-encapsulated tablets orally.
DRUG	Placebo	Placebo for alirocumab and ezetimibe.

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-04-01
• Completion: 2014-05-01
• First posted: 2012-11-21
• Last updated: 2015-08-31
• Results posted: 2015-08-31

Locations

97 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom