Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
Public ClinicalTrials.gov record NCT02798471. 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
A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed Venous Thromboembolism (VTE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.
Study identification
- NCT ID
- NCT02798471
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 290 participants
Conditions and interventions
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
- Mar 27, 2017 (Actual)
- Primary completion
- May 24, 2022 (Actual)
- Completion
- May 24, 2022 (Actual)
- Last update posted
- Feb 28, 2025
2017 – 2022
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85724 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| UCLA Medical Center CAR | Los Angeles | California | 90095 | — |
| Stanford University Medical Center | Stanford | California | 94305 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | — |
| Indiana Hemophilia and Thrombosis Center | Indianapolis | Indiana | 46260 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Spectrum Health Helen DeVos Children's Hospital Grand Rapids | Grand Rapids | Michigan | 49503 | — |
| Children's Hospital & Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University North Carolina- Chapel Hill | Chapel Hill | North Carolina | 27517 | — |
| Levine Children's Hospital Charlotte | Charlotte | North Carolina | 28204 | — |
| The Presbyterian Hospital | Charlotte | North Carolina | 28210 | — |
| East Carolina University | Greenville | North Carolina | 27858 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Hasbro Children's Hospital | Providence | Rhode Island | 02903 | — |
| Le Bonheur Childrens Hospital | Memphis | Tennessee | 38105 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 118 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02798471, 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 Feb 28, 2025 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02798471 live on ClinicalTrials.gov.