Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe in Patients with Hypercholesterolemia

Phase 1

• Conditions: Hypercholesterolaemia; MedDRA version: 16.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-001424-38-BE
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-26
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Patients with hypercholesterolemia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by SAR236553 (REGN727) in comparison with ezetimibe (EZE) after 24 weeks of treatment in patients with hypercholesterolemia;Secondary Objective: -To evaluate the effect of SAR236553 (REGN727) in comparison with EZE on LDL-C at other time points<br>- To evaluate the effect of SAR236553 (REGN727) on other lipid parameters<br>- To evaluate the safety and tolerability of SAR236553 (REGN727)<br>;Primary end point(s): Percent change in LDL-C;Timepoint(s) of evaluation of this end point: From baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percent change in LDL-C <br>Percent change in other lipid parameters ;Timepoint(s) of evaluation of this end point: From baseline up to week 12 for Percent change in LDL-C <br>From baseline up to week 24 for Percent change in other lipid parameters <br>