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NCT01519167 · ClinicalTrials.gov registry record · Phase 4
Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation
A Phase 4 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 91
- Enrollment target
NCT01519167 is a Phase 4 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 91 participants.
The verdict
NCT01519167, a Phase 4 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 91 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01519167
The ClinicalTrials.gov registry entry for NCT01519167 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01519167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01519167 about?
NCT01519167 is a clinical study titled "Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation". The objective of this study is to evaluate the safety of dexmedetomidine in a pediatric population requiring non-intubated, spontaneous breathing, moderate to deep sedation (NI-MDS) for elective diagnostic or therapeutic procedures, expected to take more than 30 minutes.
What is the current status of trial NCT01519167?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 91 participants. The study started on 2012-10. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01519167?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT01519167?
This trial is sponsored by Hospira, now a wholly owned subsidiary of Pfizer, which has 15 total clinical trials registered on ClinicalTrials.gov.
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