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Phase II, Open-Label, Single Center, Escalating Dose Study to Determine the Pharmacokinetic...

Full Title: Phase II, Open-Label, Single Center, Escalating Dose Study to Determine the Pharmacokinetic and Pharmacodynamic Profile of Dexmedetomidine in Pediatric Subjects Ages 12 months through <24 months of age

PI: Constantinos Chrysostomou, MD

Funding: Hospira, Inc. Lake Forest, Illinois, U.S.A

 

Purpose of Study

  • Characterize the loading and maintenance dosing of dexmedetomidine in pediatric patients 1 – 2 years of age.  
  • Evaluate the safety and efficacy of loading and maintenance infusions for sedation in pediatric ICU patients
  • Explore the exposure-response relationship between doses of dexmedetomidine and clinical measures of sedation and safety

Study Design

Phase II, randomized, open-label, single-center, study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects across two dose levels of dexmedetomidine.