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NCT03395639 · ClinicalTrials.gov registry record · Phase 3
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A Phase 3 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
NCT03395639: Completed Phase 3 study, sponsored by Daiichi Sankyo.
NCT03395639 is a Phase 3 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03395639, a Phase 3 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
Study Summary
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. The study will find out if edoxaban is safer and more effective than the standard of care.
Primary Outcome
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of \>2 g/dL, or leading to transfusion of the
Interventions
- DRUG Standard of Care (SOC)
- DRUG Edoxaban
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2021-12-03 |
| Phase | Phase 3 |
What the finished NCT03395639 record still lists
NCT03395639 is an interventional study that assigns participants to a tested intervention. The registered 168 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care (SOC) is the first listed.
NCT03395639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03395639 about?
NCT03395639 is a clinical study titled "Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease". A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. T...
What is the current status of trial NCT03395639?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2018-05-15. Estimated completion is 2021-12-03.
What interventions are being tested in trial NCT03395639?
The interventions under investigation include: Standard of Care (SOC) (DRUG), Edoxaban (DRUG).
Who is sponsoring clinical trial NCT03395639?
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 NCT03395639's enrollment target sits among peer trials
168 1459th of 2000 higher than 538 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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