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

Phase 3

Completed

• Conditions: hypercholesterolemie; high cholesterol; hypercholesterolemia

• Registration Number: NL-OMON36881
• Lead Sponsor: Sanofi-aventis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients with hypercholesterolemia at moderate cardio-vascular (CV) risk defined with a 10-year risk SCORE >=1% and < 5% based on the Systematic Coronary Risk Estimation (SCORE)

Exclusion Criteria

* Age < 18 or legal age of adulthood, whichever is greater
* LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
* Fasting serum TG > 400 mg/dL > 4.52 mmol/L)
* Known history of homozygous or heterozygous familial hypercholesterolemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percent change in LDL-C after 24 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Percent change in LDL-C Percent change after 12 weeks<br /><br>Percent change in other lipid parameters after 24 weeks</p><br>