Overview

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Status:
Completed

Trial end date:
2014-04-01

Target enrollment:

Participant gender:

Summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: - To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effect of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal