drugset / Trial / NCT01378988
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through \<24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.
Timeline
- Start
- 2011-06
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.5 ug/kg | Intravenous |
| Subject | Dexmedetomidine | Other / unclassified | 0.75 ug/kg | Intravenous |
Indications
No indication recorded.