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NCT01684423 · ClinicalTrials.gov registry record · Phase 2
Oral Rivaroxaban in Children With Venous Thrombosis
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01684423: Completed Phase 2 study, sponsored by Bayer.
NCT01684423 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01684423, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
Primary Outcome
Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * c
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Active comparator
- DRUG Rivaroxaban (BAY59-7939) suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-02-19 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 2 |
What the finished NCT01684423 record still lists
NCT01684423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT01684423 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01684423 about?
NCT01684423 is a clinical study titled "Oral Rivaroxaban in Children With Venous Thrombosis". The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
What is the current status of trial NCT01684423?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2013-02-19. Estimated completion is 2016-09-01.
What interventions are being tested in trial NCT01684423?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Active comparator (DRUG), Rivaroxaban (BAY59-7939) suspension (DRUG).
Who is sponsoring clinical trial NCT01684423?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01684423's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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