NCT01709513

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 Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia

Interventions

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

Timeline

• Start date: 2012-09-30
• Primary completion: 2014-05-31
• Completion: 2017-05-31
• First posted: 2012-10-18
• Last updated: 2020-06-23
• Results posted: 2015-08-28

Locations

70 sites across 8 countries: United States, Austria, Canada, France, Israel, Italy, Norway, United Kingdom