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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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

Key facts

Study ID

NCT01623115

Run by

Sanofi

People needed

486

Starts

2012-07-01

Expected to finish

2014-12-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840429 — Long Beach, California, United States
• Investigational Site Number 840419 — Los Angeles, California, United States
• Investigational Site Number 840421 — Mission Viejo, California, United States
• Investigational Site Number 840412 — Newport Beach, California, United States
• Investigational Site Number 840428 — Newport Beach, California, United States
• Investigational Site Number 840461 — Northridge, California, United States
• Investigational Site Number 840452 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840456 — Miami, Florida, United States
• Investigational Site Number 840418 — Ponte Vedra, Florida, United States
• Investigational Site Number 840455 — Evanston, Illinois, United States
• Investigational Site Number 840415 — Kansas City, Kansas, United States
• Investigational Site Number 840425 — Auburn, Maine, United States
• Investigational Site Number 840411 — Boston, Massachusetts, United States
• Investigational Site Number 840409 — St Louis, Missouri, United States
• Investigational Site Number 840407 — Morristown, New Jersey, United States
• Investigational Site Number 840408 — New York, New York, United States
• Investigational Site Number 840401 — Charlotte, North Carolina, United States
• Investigational Site Number 840410 — Durham, North Carolina, United States
• Investigational Site Number 840430 — Cincinnati, Ohio, United States
• Investigational Site Number 840424 — Portland, Oregon, United States
• Investigational Site Number 840404 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840426 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840406 — Nashville, Tennessee, United States
• Investigational Site Number 840460 — Dallas, Texas, United States
• Investigational Site Number 840417 — Bell Gardens, California, United States

Full record on ClinicalTrials.gov

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