Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Mise à jour : Il y a 5 ans
Référence : NCT01644188

Femme et Homme

Extrait

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). 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 in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with ezetimibe 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


Critère d'inclusion

  • Hypercholesterolemia


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