Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolaemia

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

NCT01617655

Run by

Sanofi

People needed

107

Starts

2012-06-01

Expected to finish

2015-01-01

Last updated by the study team

2016-10-04

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
• LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).
• Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.
• 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 840742 — Bell Gardens, California, United States
• Investigational Site Number 840703 — Newport Beach, California, United States
• Investigational Site Number 840712 — Newport Beach, California, United States
• Investigational Site Number 840743 — Northridge, California, United States
• Investigational Site Number 840734 — Washington D.C., District of Columbia, United States
• Investigational Site Number 840738 — Miami, Florida, United States
• Investigational Site Number 840710 — Ponte Vedra, Florida, United States
• Investigational Site Number 840701 — New York, New York, United States
• Investigational Site Number 840702 — Durham, North Carolina, United States
• Investigational Site Number 840714 — Cincinnati, Ohio, United States
• Investigational Site Number 840705 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840709 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840713 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 840736 — Dallas, Texas, United States
• Investigational Site Number 124704 — Québec, Canada
• Investigational Site Number 124703 — Sherbrooke, Canada
• Investigational Site Number 528713 — Amsterdam, Netherlands
• Investigational Site Number 528701 — Amsterdam, Netherlands
• Investigational Site Number 528704 — Groningen, Netherlands
• Investigational Site Number 528716 — Leiden, Netherlands
• Investigational Site Number 528709 — Utrecht, Netherlands
• Investigational Site Number 643706 — Arkhangelsk, Russia
• Investigational Site Number 643705 — Kazan', Russia
• Investigational Site Number 643703 — Moscow, Russia
• Investigational Site Number 643711 — Moscow, Russia

Full record on ClinicalTrials.gov

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