Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
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 demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points * To evaluate the effect of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab
Key facts
- Study ID
- NCT01644474
- Run by
- Sanofi
- People needed
- 103
- Starts
- 2012-07-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2015-11-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with hypercholesterolemia
You may not qualify if…
- Age < 18 or legal age of adulthood, whichever was greater
- LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
- Fasting serum triglycerides (TG) > 400 mg/dL (> 4.52 mmol/L)
- Known history of homozygous or heterozygous familial hypercholesterolemia
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where it is running
- Investigational Site Number 840603 — Overland Park, Kansas, United States
- Investigational Site Number 840601 — Cincinnati, Ohio, United States
- Investigational Site Number 840602 — Richmond, Virginia, United States
- Investigational Site Number 056601 — Antwerp, Belgium
- Investigational Site Number 246601 — Helsinki, Finland
- Investigational Site Number 528602 — Groningen, Netherlands
- Investigational Site Number 528601 — Rotterdam, Netherlands
- Investigational Site Number 528603 — Velp, Netherlands
Full record on ClinicalTrials.gov
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