Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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21 December 2021 |
Main ID: |
EUCTR2011-005698-21-IT |
Date of registration:
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11/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome - ODYSSEY OUTCOMES
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome - ODYSSEY OUTCOMES |
Date of first enrolment:
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11/02/2013 |
Target sample size:
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18000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005698-21 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Austria
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Belarus
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Belgium
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Israel
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Italy
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Korea, Democratic People's Republic of
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Korea, Republic of
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Latvia
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Lithuania
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Peru
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Philippines
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Poland
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Portugal
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Russian Federation
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Singapore
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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CONTACT POINT
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Address:
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VIALE BODIO, 37/B
20158
MILANO
Italy |
Telephone:
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800.226343 |
Email:
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informazioni.medicoscientifiche@sanofi-aventis.com |
Affiliation:
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SANOFI-AVENTIS S.P.A. |
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Name:
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CONTACT POINT
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Address:
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VIALE BODIO, 37/B
20158
MILANO
Italy |
Telephone:
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800.226343 |
Email:
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informazioni.medicoscientifiche@sanofi-aventis.com |
Affiliation:
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SANOFI-AVENTIS S.P.A. |
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Key inclusion & exclusion criteria
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Inclusion criteria: Recently hospitalized for ACS Are the trial subjects under 18? no Number of subjects for this age range: 0 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: Age < 40 years. - ACS event occurring more than 16 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Acute Coronary Syndrome MedDRA version: 14.1
Level: PT
Classification code 10051592
Term: Acute coronary syndrome
System Organ Class: 10007541 - Cardiac disorders
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Intervention(s)
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Product Name: NA Product Code: SAR236553 (REGN/727) Pharmaceutical Form: Solution for injection CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN/727) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
Product Name: NA Product Code: SAR236553 (REGN/727) Pharmaceutical Form: Solution for injection CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN/727) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To evaluate the effect of SAR236553 (REGN727) on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality). To evaluate the safety and tolerability of SAR236553 (REGN727). To evaluate the effect of SAR236553 (REGN727) on lipid parameters
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Primary end point(s): Time from randomization to first occurrence of one of the following Clinical Events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization
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Timepoint(s) of evaluation of this end point: Up to Month 64
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Main Objective: To compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia
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Secondary Outcome(s)
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Secondary end point(s): Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality - Change from baseline in blood lipids and lipoprotein levels - Number of patients with adverse events
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Timepoint(s) of evaluation of this end point: Up to Month 64
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Secondary ID(s)
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2011-005698-21-GB
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EFC11570
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Source(s) of Monetary Support
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SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
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Ethics review
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Status: Approved
Approval date: 29/11/2012
Contact:
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