Overview

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

Status:
Completed

Trial end date:
2013-07-01

Target enrollment:
0

Participant gender:
All

Summary

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 in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. 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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals

Treatments:

Antibodies, Monoclonal
Ezetimibe

Criteria

Inclusion criteria:

- Participants with hypercholesterolemia

Exclusion criteria:

- Age < 18 or legal age of adulthood, whichever was greater

- LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)

- Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L)

- Known history of homozygous or heterozygous familial hypercholesterolemia

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.