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-ES
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 2 February 2015

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:
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