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Clinical Trials/EUCTR2011-005109-56-GB
EUCTR2011-005109-56-GB
Active, not recruiting
Not Applicable

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

sanofi-aventis Recherche & Développement0 sites802 target enrollmentJuly 5, 2012
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ConditionsHypercholesterolaemiaMedDRA version: 15.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypercholesterolaemia
Sponsor
sanofi-aventis Recherche & Développement
Enrollment
802
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 5, 2012
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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