Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients with Heterozygous Familial Hypercholesterolemia
- Conditions
- HypercholesterolaemiaMedDRA version: 14.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-005109-56-CZ
- 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