Study Details
A study of mirabegron in young children with neurogenic detrusor overactivity
Clinicaltrials.gov ID
Astellas Study ID
178-CL-207
EudraCT ID
2021-005455-37
Condition
Bladder Disease
Phase
Phase 3
Age
6 Months - 3 Years
Sex
Female & Male
Product
mirabegron + solifenacin succinate
Type
Interventional
Trial Dates
Aug 2023 - Jul 2025
Masking
None (Open Label)
Enrollment number
10
A Phase 3, Open Label, Multicenter, Baseline-Controlled Sequential Dose Titration Study Followed by a Fixed Dose Observation Period to Evaluate Pharmacokinetics, Efficacy and Safety of Mirabegron Prolonged-Release Microgranula-Based Suspension in Children from 6 Months to Less Than 3 Years of Age with Neurogenic Detrusor Overactivity
Study summary
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