Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2012
End Date:	December 2014

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9
(proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels
after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

- To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time
points

- To evaluate the effects of alirocumab on other lipid parameters

- To evaluate the safety and tolerability of alirocumab

The maximum study duration was planned to be 89 weeks per participant including participants
who successfully completed the 78-week treatment period had the possibility to join an
open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

Inclusion criteria:

- Participants with heterozygous familial hypercholesterolemia who were not adequately
controlled with their lipid-modifying therapy

Exclusion criteria:

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

- LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease

- LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease

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

- Known history of homozygous familial hypercholesterolemia

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

We found this trial at

sites

Clinical Trial Facility in Morristown New Jersey

Morristown, New Jersey 07960

from

Morristown, NJ