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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 July 2022 |
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Main ID: |
NCT03395639 |
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Date of registration:
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04/01/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
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Scientific title:
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An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events |
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Date of first enrolment:
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May 15, 2018 |
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Target sample size:
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168 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03395639 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Canada
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Croatia
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Egypt
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France
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Germany
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Hungary
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India
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Israel
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Italy
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Lebanon
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Poland
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Russian Federation
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Spain
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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 Leader |
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Address:
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Telephone:
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Email:
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Affiliation:
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Daiichi Sankyo, Inc. |
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Source(s) of Monetary Support
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