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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26 February 2018 |
Main ID: |
EUCTR2011-005698-21-LV |
Date of registration:
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04/12/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
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Scientific title:
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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 |
Date of first enrolment:
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29/04/2013 |
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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Bosnia and Herzegovina
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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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France
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Georgia
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Germany
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Greece
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Guatemala
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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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Japan
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Korea, Republic of
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Latvia
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Lithuania
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Macedonia, the former Yugoslav Republic of
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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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Romania
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Russian Federation
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Serbia
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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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Sri Lanka
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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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Clinical Study Unit
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Address:
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Kr. Valdemara 33-8
1010
Riga
Latvia |
Telephone:
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+371 67 33 2451 |
Email:
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Clinicaltrials.Latvia@sanofi-aventis.com |
Affiliation:
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sanofi –aventis Latvia SIA |
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Name:
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Clinical Study Unit
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Address:
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Kr. Valdemara 33-8
1010
Riga
Latvia |
Telephone:
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+371 67 33 2451 |
Email:
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Clinicaltrials.Latvia@sanofi-aventis.com |
Affiliation:
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sanofi –aventis Latvia SIA |
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Key inclusion & exclusion criteria
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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.
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] - Nutritional and Metabolic Diseases [C18]
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Acute coronary syndrome MedDRA version: 17.0
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 Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection INN or Proposed INN: alirocumab CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN727) 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 Code: SAR236553 (REGN727) Pharmaceutical Form: Solution for injection INN or Proposed INN: alirocumab CAS Number: 1245916-14-6 Current Sponsor code: SAR236553 (REGN727) 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 alirocumab 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 alirocumab. To evaluate the effect of alirocumab 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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Main Objective: To compare the effect of alirocumab 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 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.
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Timepoint(s) of evaluation of this end point: Up to Month 64
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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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EFC11570
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2011-005698-21-GB
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Source(s) of Monetary Support
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sanofi-aventis Recherche & Développement
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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