ong-term safety and tolerability of SAR236553 (REGN727) 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: EUCTR2011-002806-59-IT

Lead Sponsor: SANOFI- AVENTIS RECHERCHE ET DÃ‰VELOPPEMENT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2100

Inclusion Criteria

Either A or B below and not adequately controlled with a maximally tolerated stable daily dose of statin for at least 4 weeks prior to the screening visit with or without other lipid modifying therapy (LMT). A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 630

Exclusion Criteria

• LDL-C <100 mg/dL (< 2.59 mmol/L) at the screening visit • Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit or from screening to randomization. • Currently taking a statin that is not simvastatin, atorvastatin, or rosuvastatin taken daily at a registered dose. • Fasting serum TG > 400 mg/dL (>4.52 mmol/L) at the screening visit

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of SAR236553(REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).;Secondary Objective: To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the efficacy of SAR236553 (REGN727) on LDL-C levels at other time points;Primary end point(s): Assessment of safety parameters (adverse events [including adjudicated cardiovascular events, laboratory data, vital signs, and ECG;Timepoint(s) of evaluation of this end point: Up to 20 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percent change in calculated low density lipoprotein cholesterol (LDL-C);Timepoint(s) of evaluation of this end point: From baseline to week 24