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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: Completed Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Clinical Score Level of Sedation 0 Awake/Alert 1. Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2. Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3. Deeply sedated: Deep sleep, arousable only with significant physical stimulation. 4. Unarousable
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 |
What the finished NCT00875550 record still lists
NCT00875550 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Midazolam is the first listed.
NCT00875550 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00875550's enrollment target sits among peer trials
175 1440th of 2000 higher than 559 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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