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NCT00875550 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
A Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT00875550 is a Phase 3 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 175 participants.
The verdict
NCT00875550, a Phase 3 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are: * To characterize the loading and maintenance dosing of DEX by age group and overall medical condition of pediatric subjects * To evaluate the safety and efficacy of loading and maintenance infusions for sedation in initially intubated and mechanically ventilated PICU subjects * To explore the exposure-response relationship between dose of DEX and clinical measures of sedation and safety
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Morphine
- DRUG Fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00875550
The ClinicalTrials.gov registry entry for NCT00875550 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 175 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 4 interventions - of which Midazolam is the first listed.
NCT00875550 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00875550 about?
NCT00875550 is a clinical study titled "Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects". The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects. The key study objectives are: * To characterize the loading and maintenance dosing of DEX by age group and overall medica...
What is the current status of trial NCT00875550?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2010-01. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00875550?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Morphine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT00875550?
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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