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 of alirocumab (REGN727/SAR236553) in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Enrollment: 314
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Arms:
- Atorvastatin
- Active Comparator: Ezetimibe
- Experimental: Alirocumab 75/ up to 150