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

PHASE3CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

July 20, 2016

Primary Completion Date

May 24, 2017

Study Completion Date

May 24, 2017

Conditions
ICU Sedation
Interventions
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"

Trial Locations (12)

078-8510

Asahikawa Medical University Hospital, Asahikawa

650-0047

Hyogo Prefectural Kobe Children's Hospital, Kobe

765-8507

Shikoku Medical Center for Children and Adults, Zentsujichó

594-1101

Osaka Women's and Children's Hospital, Izumi

569-8686

Osaka Medical College Hospital, Takatsuki

329-0498

Jichi Medical University Hospital, Shimotsuke

113-8431

Juntendo University Hospital, Bunkyo-ku

183-8561

Tokyo Metropolitan Children's Medical Center, Fuchū

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

700-8558

Okayama University Hospital, Okayama

534-0021

Osaka City General Hospital, Osaka

420-8660

Shizuoka Children's Hospital, Shizuoka

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Maruishi Pharmaceutical

INDUSTRY

lead

Pfizer

INDUSTRY

NCT02757625 - Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit | Biotech Hunter | Biotech Hunter