Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2011-005109-56-NL
EUCTR2011-005109-56-NL
Active, not recruiting
Phase 1

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 sites486 target enrollmentJuly 31, 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
sanofi-aventis Recherche & Développement
Enrollment
486
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 31, 2012
End Date
December 5, 2014
Last Updated
4 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

Similar Trials

Active, not recruiting
Not Applicable
Efficacy and Safety of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients with Heterozygous Familial HypercholesterolemiaHypercholesterolaemiaMedDRA version: 15.1Level: PTClassification code 10020603Term: HypercholesterolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-005109-56-GBsanofi-aventis Recherche & Développement802
Active, not recruiting
Phase 1
A study of Baricitinib in patients with LupusSystemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
EUCTR2017-005026-37-GREli Lilly and Company821
Not yet recruiting
Not Applicable
A Clinical Study to Evaluate the Efficacy and Safety of ViphyllinTM on Brain function and overall cognitive function.
CTRI/2022/05/042935Vidya Herbs Pvt Ltd
Active, not recruiting
Phase 1
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
EUCTR2011-005698-21-HRsanofi-aventis Recherche & Développement18,924
Active, not recruiting
Phase 1
A study in LupusPatients with Systemic Lupus Erythematosus (SLE)MedDRA version: 18.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
EUCTR2015-004404-35-ESilly S.A.300