At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 69 enrolled
Drug / intervention
Dexmedetomidine, midazolam; fentanyldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label, Multicenter, Escalating Dose, Study to Determine Pharmacokinetic and Pharmacodynamic Profile of Dexmedetomidine in Pediatric Subjects Ages ≥ 2 Through < 17 Years Old
Hospira, now a wholly owned subsidiary of Pfizer·interventional·Posted Apr 3, 2008·Updated Apr 13, 2017
In Brief
A Phase 2 clinical trial evaluating Dexmedetomidine, midazolam; fentanyl for Intubated and Mechanically Ventilated Pediatric Subjects. Completed, enrolled 69 participants across 9 sites in 2 countries.
Detailed Summary
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects ages ≥2 through \<17 years old.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGuatemala, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2008
Enrollment StartNov 2008
Primary CompletionApr 2010
TodayJul 2026
First PostedApr 3, 2008
Enrollment StartNov 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.2 years ago
Interventions
Dexmedetomidine, midazolam; fentanyldrug
Dexmedetomidine for sedation; midazolam for rescue sedation according to label; fentanyl for rescue pain according to the label