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NCT00398827 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
A Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT00398827: Completed Phase 3 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT00398827 is a Phase 3 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398827, a Phase 3 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
Primary Outcome
Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (Responsiveness: Lethargic response to name spoken in normal tone; Speech: Mild slowing or thickening; Facial Expression: Mild relaxation; Eyes: Glazed or mild ptosis \[less than half the eye\])
Interventions
- DRUG Placebo
- DRUG Dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-05 |
| Phase | Phase 3 |
What the finished NCT00398827 record still lists
NCT00398827 is an interventional study that assigns participants to a tested intervention. The registered 326 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00398827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00398827 about?
NCT00398827 is a clinical study titled "A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)". The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
What is the current status of trial NCT00398827?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2006-12. Estimated completion is 2007-05.
What interventions are being tested in trial NCT00398827?
The interventions under investigation include: Placebo (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT00398827?
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 NCT00398827's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 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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