ong-term Safety and Tolerability of SAR236553 (REGN727) VersusPlacebo on Top of Lipid-Modifying Therapy in High Cardiovascular RiskPatients with Hypercholesterolemia.
- Conditions
- Hypercholesterolaemia.MedDRA version: 14.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-002806-59-GB
- Lead Sponsor
- sanofi-aventis Recherche & Développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5250
Inclusion Criteria
Either A or B below and who are not adequately controlled with their lipid-modifying therapy.
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2940
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2310
Exclusion Criteria
Age < 18 years.
LDL-C <70 mg/dL (< 1.81 mmol/L).
Fasting serum TG > 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 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.<br>- 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;Primary end point(s): Assessment of safety parameters (adverse 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).<br>Percent change in calculated LDL-C.<br>Percent change in other lipid parameters.;Timepoint(s) of evaluation of this end point: From baseline to week 24 for Percent change in calculated low density lipoprotein cholesterol (LDL-C).<br>From baseline to week 78 for Percent change in calculated LDL-C and Percent change in other lipid parameters.