Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
Public ClinicalTrials.gov record NCT03395639. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03395639
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Daiichi Sankyo
- Industry
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Interventions
- Edoxaban Drug
- Standard of Care (SOC) Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Day to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2018
- Primary completion
- Dec 2, 2021
- Completion
- Dec 2, 2021
- Last update posted
- Jul 25, 2022
2018 – 2021
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Cardon Childrens Medical Center | Mesa | Arizona | 85202 | — |
| Cedars Sinai Medical Center (ECG) | Los Angeles | California | 90048 | — |
| University of California-San Francisco Department of Pediatrics - Hematology/Oncology | San Francisco | California | 94158 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Novant Health Heart and Vascular institute | Charlotte | North Carolina | 28204 | — |
| East Carolina Heart Institute @ ECU | Greenville | North Carolina | 27834 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03395639, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2022 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03395639 live on ClinicalTrials.gov.