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NCT02215148 · ClinicalTrials.gov registry record
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- 1
- Enrollment target
NCT02215148: Clinical Trial study, sponsored by University of North Carolina, Chapel Hill.
NCT02215148 is a clinical trial that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02215148 was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- 1 participants
- Enrollment target
Study Summary
To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute brain injured patients
Primary Outcome
Cmax will be derived from plasma concentrations versus time using a validated LS/MS/MS assay is sodium heparinized plasma. The tolvaptan assay has a range of 1.00 - 200 mg/mL. Blood samples will be collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 20, 24, 30 and 36 hours after the dose of tolvaptan is administered. The first 15 patients will receive single dose 15mg of tolvaptan via a gastric tube and if determined not bioequivalent and no clinical response to oral administration and safe to a
Interventions
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-08 |
Why NCT02215148 stopped before completion
NCT02215148 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT02215148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02215148 about?
NCT02215148 is a clinical study titled "Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients". To assess the pharmacokinetic profile of tolvaptan in critically ill acute brain injury patients and to secondarily evaluate the clinical response and safety of tolvaptan in acute brain injured patients
What is the current status of trial NCT02215148?
This trial is currently terminated. The enrollment target is 1 participants. The study started on 2014-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02215148?
The interventions under investigation include: Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT02215148?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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