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NCT01159262 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
A Phase 2 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01159262: Completed Phase 2 study, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
NCT01159262 is a Phase 2 study that has completed, run by Hospira, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01159262, a Phase 2 study, has completed, sponsored by Hospira, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Fentanyl/Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT01159262 record still lists
NCT01159262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Midazolam is the first listed.
NCT01159262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01159262 about?
NCT01159262 is a clinical study titled "Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age". The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to ...
What is the current status of trial NCT01159262?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01159262?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Fentanyl/Morphine (DRUG).
Who is sponsoring clinical trial NCT01159262?
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 NCT01159262's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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