Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | July 2013 |
A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy And Safety of SAR236553/REGN727 Over 24 Weeks in Patients With Hypercholesterolemia
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
(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
The maximum study duration was 34 weeks per participant, including a 24-week randomized
treatment period.
treatment period.
Inclusion criteria:
- Participants with hypercholesterolemia
Exclusion criteria:
- 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.
We found this trial at
4
sites
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