NCT02211846

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

A Multicentre, Open-label, Single Ascending Dose Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS Tablets in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics as well as the safety and tolerability of mirabegron OCAS tablets after single-dose administration at different dose levels in children and adolescents with NDO or OAB.

Conditions

• Neurogenic Detrusor Overactivity
• Overactive Bladder
• Pharmacokinetics of Mirabegron

Interventions

Type	Name	Description
DRUG	Mirabegron	oral

Timeline

• Start date: 2014-09-21
• Primary completion: 2015-09-21
• Completion: 2015-09-21
• First posted: 2014-08-08
• Last updated: 2024-10-22

Locations

13 sites across 5 countries: Belgium, Denmark, Norway, Poland, Serbia