Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe in 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: EUCTR2011-001424-38-FI
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Patients with hypercholesterolemia
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 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Age < 18 or legal age of adulthood, whichever is greater
LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
Fasting serum TG > 400 mg/dL (> 4.52 mmol/L)
Known history of homozygous or heterozygous familial hypercholesterolemia

Study & Design

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