Overview

Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Status:
Completed

Trial end date:
2011-12-01

Target enrollment:

Participant gender:

Summary

Primary Objective: - To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: - To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo - To evaluate the safety and tolerability of alirocumab - To evaluate the development of anti-alirocumab antibodies - To evaluate the pharmacokinetics of alirocumab

Phase:

Phase 2

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Atorvastatin
Atorvastatin Calcium