NCT02757625

Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

Phase 3, Multi-center, Single-arm, Open-label Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of Da-9501 (Dexmedetomidine Hydrochloride) In Pediatric Subjects In The Intensive Care Unit

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 45 Weeks – 16 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects \[≥ 45 weeks CGA (corrected gestational age) to \<17 years old\] requiring sedation under intensive care unit

Conditions

• ICU Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine hydrochloride	* 45 weeks CGA to \< 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state * 6 years old to \< 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state

Timeline

• Start date: 2016-07-20
• Primary completion: 2017-05-24
• Completion: 2017-05-24
• First posted: 2016-05-02
• Last updated: 2018-12-17
• Results posted: 2018-12-17

Locations

12 sites across 1 country: Japan