Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients with Heterozygous Familial Hypercholesterolemia

Phase 1

• 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: EUCTR2011-005109-56-NL
• Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-31
• Study Completion: 2014-12-05
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy
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 682
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Age < 18 years or legal age of adulthood, whichever is greater
LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
Known history of homozygous familial hypercholesterolemia

Study & Design

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