Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients with Heterozygous Familial Hypercholesterolemia

Conditions: Hypercholesterolaemia
MedDRA version: 15.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-005109-56-GB

Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 802

Inclusion Criteria

Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy
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 682
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Age < 18 years or legal age of adulthood, whichever is greater
LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
Known history of homozygous 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 evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo;Secondary Objective: To evaluate the effect of SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points<br>To evaluate the effects 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 <br>;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 78