Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Hospira, Inc. Hospira, now a wholly owned subsidiary of Pfizer