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NCT02289703 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02289703 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 16 participants.
The verdict
NCT02289703, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine clearance (CLcr) greater than equal to (\>=) 80 milliliter per minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on maintenance hemodialysis (a method used to remove waste material from the blood when the kidneys are unable to do so).
Interventions
- DRUG Rivaroxaban 15 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02289703
The ClinicalTrials.gov registry entry for NCT02289703 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rivaroxaban 15 mg is the first listed.
NCT02289703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02289703 about?
NCT02289703 is a clinical study titled "A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis". The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine ...
What is the current status of trial NCT02289703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02289703?
The interventions under investigation include: Rivaroxaban 15 mg (DRUG).
Who is sponsoring clinical trial NCT02289703?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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