A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 21, 2014

Primary Completion Date

September 21, 2015

Study Completion Date

September 21, 2015

Conditions
Neurogenic Detrusor OveractivityOveractive BladderPharmacokinetics of Mirabegron
Interventions
DRUG

Mirabegron

oral

Trial Locations (13)

2100

Site DK45005 Rigshospitalet, Copenhagen

2650

Site BE32009 Univ.Ziekenhuis Antwerpen, Edegem

3000

Site BE32011 U.Z. Leuven, Leuven

4600

Site DK45004 Børnelægen i Køge, Koege

5021

Site NO47001 Haukeland Sykehus, Bergen

6000

Site DK45002 Kolding Sygehus, Kolding

8200

Site DK45001 Uni Hosp of Aarhus, Skejby, Aarhus

8500

Site BE32004 AZ Groeninge, Campus Vercruyss, Kortrijk

9000

Site BE32003 Gent University Hospital, Ghent

Site DK45003 Aalborg Sygehus Nord, Aalborg

11000

Site RS38010 Mother and Child Health Care, Belgrade

80-952

Site PL48003 Uniwersyteckie Centrum Kliniczne, Gdansk

04-730

Site PL48001 Pomnik-Centrum Zdrowia Dziecka, Warsaw

Sponsors
All Listed Sponsors
collaborator

Astellas Pharma Europe B.V.

INDUSTRY

lead

Astellas Pharma Inc

INDUSTRY