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NCT00216190 · ClinicalTrials.gov registry record · Phase 4
A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation
A Phase 4 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 420
- Enrollment target
NCT00216190: Completed Phase 4 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT00216190 is a Phase 4 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 420 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216190, a Phase 4 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 420 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.
Primary Outcome
RASS Range: Score +1 (Restless: Anxious; but movements not aggressive or vigorous) Score 0 (Alert and calm) Score -1 (Drowsy: Not fully alert, but has sustained awakening \[eye opening/eye contact\] to voice \[≥10 seconds\]) Score -2 (Light sedation: Briefly awakens with eye contact to voice \[\< 10 seconds\])
Interventions
- DRUG Dexmedetomidine HCL Injection
- DRUG Midazolam Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2005-03 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT00216190 record still lists
NCT00216190 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine HCL Injection is the first listed.
NCT00216190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00216190 about?
NCT00216190 is a clinical study titled "A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation". The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.
What is the current status of trial NCT00216190?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 420 participants. The study started on 2005-03. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00216190?
The interventions under investigation include: Dexmedetomidine HCL Injection (DRUG), Midazolam Injection (DRUG).
Who is sponsoring clinical trial NCT00216190?
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 NCT00216190's enrollment target sits among peer trials
420 201st of 2000 higher than 1,799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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