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NCT02798471 · ClinicalTrials.gov registry record · Phase 3
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 290
- Enrollment target
NCT02798471: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT02798471 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02798471, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 290 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis.
Interventions
- DRUG Standard of Care
- DRUG Edoxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2017-03-27 |
| Est. Completion | 2022-05-24 |
| Phase | Phase 3 |
What the finished NCT02798471 record still lists
NCT02798471 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02798471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02798471 about?
NCT02798471 is a clinical study titled "Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)". 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 ...
What is the current status of trial NCT02798471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. The study started on 2017-03-27. Estimated completion is 2022-05-24.
What interventions are being tested in trial NCT02798471?
The interventions under investigation include: Standard of Care (DRUG), Edoxaban (DRUG).
Who is sponsoring clinical trial NCT02798471?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02798471's enrollment target sits among peer trials
290 1171st of 2000 higher than 828 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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