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
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
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.