Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2011-005698-21-HR
EUCTR2011-005698-21-HR
Active, not recruiting
Phase 1

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

sanofi-aventis Recherche & Développement0 sites18,924 target enrollmentSeptember 3, 2014
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsPraluent

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
sanofi-aventis Recherche & Développement
Enrollment
18924
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 3, 2014
End Date
January 23, 2018
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •o Recently (\< 52 weeks) hospitalized for ACS.
  • •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 16000
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 2600

Exclusion Criteria

  • •o Age \< 40 years.
  • •o ACS event occurring more than 52 weeks prior to randomization visit.
  • •o LDL\-C likely to be \<70 mg/dL (\<1\.81 mmo/L) with evidence\-based medical and dietary management of dyslipidemia.

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
Active, not recruiting
Phase 1
albuphine HCL ER Tablets in Prurigo Nodularis Patients
EUCTR2013-005627-17-DETrevi Therapeutics, Inc.60
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
Active, not recruiting
Not Applicable
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of Migraine - Efficacy study of 333369 for the Prophylaxis of Migraine
EUCTR2004-004162-33-DEJanssen Cilag International NV300