Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients with Hypercholesterolemia

Conditions: Hypercholesterolaemia
MedDRA version: 14.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-004130-34-HU

Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 660

Inclusion Criteria

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2)
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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330

Exclusion Criteria

Age < 18 or legal age of adulthood, whichever is greater.
Patients without established CHD or CHD risk equivalents.
LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

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) as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.;Secondary Objective: To evaluate the effect of SAR236553 (REGN727) in comparison with ezetimibe 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: Percent change in LDL-C: From baseline up to week 12<br><br>Percent change in other lipid parameters: At weeks 12 and 24