Overview

Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)

Status:
Completed

Trial end date:
2015-09-01

Target enrollment:

Participant gender:

Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia (HeFH) or high cardiovascular risk participants with hypercholesterolemia. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment. - To evaluate the effect of alirocumab on other lipid parameters. - To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment. - To evaluate the safety and tolerability of alirocumab. - To evaluate the development of anti-alirocumab antibodies. - To evaluate the pharmacokinetics of alirocumab.

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal