CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Dexmedetomidine hydrochloridedrug
Likely dose
Dexmedetomidine 0.2–1.4 µg/kg/h maintenance infusion (titrated based on sedative state)AI-extracted
Key inclusion· 4
  • ✓Age ≥45 weeks corrected gestational age (CGA) to <17 years old at time of consent
  • ✓Elective surgical cases: ASA Class I–III
  • ✓Elective surgical cases: require ≥6 hours respiratory management with intubation post-surgery and anticipated to need sedation
  • ✓Medical ICU cases: require ≥24 hours respiratory management with intubation and anticipated to need sedation; prior sedatives must be discontinued before starting investigational product
Key exclusion· 11
  • ✕Neurological disease making sedation assessment difficult (brain damage with elevated intracranial pressure, cerebral palsy, autism, severe mental retardation, or paralysis from muscle relaxant or spinal injury T5 or higher)
  • ✕2nd or 3rd degree heart block (excluding those with pacemaker)
  • ✕Low blood pressure: <70 mmHg (45 weeks–<1 year), <70 + (2×age years) mmHg (1–<10 years), <90 mmHg (≥10–<17 years)
  • ✕Bradycardia (≤10th centile for healthy children) at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02757625
NCT02757625Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted May 2, 2016·Updated Dec 17, 2018

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine hydrochloride for ICU Sedation. Completed, enrolled 63 participants across 12 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsICU Sedation
CountriesJapan
CollaboratorsMaruishi Pharmaceutical

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartJul 20, 2016
Primary CompletionMay 24, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.2 years ago

Interventions

Dexmedetomidine hydrochloridedrug

* 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