Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia (ODYSSEY Mono)

Primary Objective:
The purpose of this study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab SAR236553 (REGN727) in comparison with ezetimibe (EZE) after 24 weeks of treatment in patients with hypercholesterolemia

Secondary Objectives:
   - To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with EZE on LDL-C at other time points
   - To evaluate the effect of alirocumab SAR236553 (REGN727) on other lipid parameters
   - To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727)


Study Type: Interventional    
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy And Safety of SAR236553/REGN727 Over 24 Weeks in Patients With Hypercholesterolemia
Enrollment: 103
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)

Arms:
- Experimental: alirocumab SAR236553 (REGN727)/Ezetimibe placebo
- Active Comparator: alirocumab SAR236553 (REGN727) Placebo/ Ezetimibe