CompletedPhase 3

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

United States486 participantsStarted 2012-07

Plain-language 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 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

Timeframe: From Baseline to Week 52

Trial details

NCT IDNCT01623115

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04

Results submitted2015-08-20