ong-term safety and tolerability of SAR236553 (REGN727) versus placebo on top of lipid-modifying therapy in high cardiovascular risk patients with hypercholesterolemia.

• Conditions: Hypercholesterolaemia.; MedDRA version: 16.0Level: 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-BE
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-09
• Last Update Posted: 17 August 2015

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 triglycerides > 400 mg/dL (>4.52 mmol/L)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified