EUCTR2011-005698-21-EE
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
ConditionsAcute coronary syndromeMedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsPraluent
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute coronary syndrome
- Sponsor
- sanofi-aventis Recherche & Développement
- Enrollment
- 18600
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
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
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