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Clinical Trials/EUCTR2011-005698-21-SE
EUCTR2011-005698-21-SE
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 - Odyssey Outcomes

sanofi-aventis Recherche & Développement0 sites18,000 target enrollmentNovember 1, 2012
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ConditionsAcute coronary syndromeMedDRA version: 17.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Acute coronary syndrome
Sponsor
sanofi-aventis Recherche & Développement
Enrollment
18000
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 1, 2012
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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 15500
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 2500

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

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ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With AlirocumabAcute coronary syndromeMedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
EUCTR2011-005698-21-EEsanofi-aventis Recherche & Développement18,600