Efficacy and Safety of SAR236553 (REGN727) Versus Ezetimibe on Top of Statin 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: EUCTR2011-004130-34-DE
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-31
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2)
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 330
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330

Exclusion Criteria

Age < 18 or legal age of adulthood, whichever is greater.
Patients without established CHD or CHD risk equivalents.
LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

Study & Design

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