NCT04641975

A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

A Phase 3, Double-blind, Randomized, Multicenter, Parallel Group, Placebo-controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects From 5 to < 18 Years of Age With Overactive Bladder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to \< 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and evaluated the pharmacokinetics after multiple dose administration of mirabegron in pediatric participants with OAB.

Detailed description

The study consisted of 3 periods (Screening period/urotherapy (4 weeks); Double-blind, placebo-controlled period (12 weeks); Follow-up period (2 weeks)) for a total duration of 18 weeks.

Conditions

• Overactive Bladder (OAB)
• Pharmacokinetics of Mirabegron

Interventions

Type	Name	Description
DRUG	Mirabegron	Oral/ Oral Suspension: Participants with a body weight of ≥ 35 kg are to receive the tablet form of IP unless unable to swallow tablets and will be provided the oral suspension as an alternative. Participants with a body weight \< 35 kg or those who cannot be dosed with the tablet will receive oral suspension.
DRUG	Placebo	Oral/ Oral Suspension

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-07-07
• Completion: 2023-07-24
• First posted: 2020-11-24
• Last updated: 2024-11-14
• Results posted: 2023-12-28

Locations

15 sites across 10 countries: Belgium, France, Malaysia, Norway, Philippines, Russia, South Korea, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study