Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01145859 · ClinicalTrials.gov registry record · Phase 1
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
NCT01145859: Completed Phase 1 study, sponsored by Bayer.
NCT01145859 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 59 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01145859, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
Study Summary
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01145859 record still lists
NCT01145859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT01145859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01145859 about?
NCT01145859 is a clinical study titled "Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects". The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatr...
What is the current status of trial NCT01145859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2010-11. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01145859?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG).
Who is sponsoring clinical trial NCT01145859?
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 NCT01145859's enrollment target sits among peer trials
59 895th of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03801083 · 59 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
- NCT04332367 · 59 participants · Phase 2
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
- NCT05489575 · 59 participants · NA
CPAP for the Treatment of Supine Hypertension
- NCT06721689 · 59 participants · Phase 1
PEEL-224, Vincristine and Temozolomide in Pediatric Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia