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Clinical trial

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

NCT05621616 is registered in ClinicalTrials.gov with Astellas Pharma Global Development, Inc. as lead sponsor.

NCT NCT05621616
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Astellas Pharma Global Development, Inc.
Phase
Phase 3
Overall status
Completed
Start date
February 28, 2024
Completion date
September 17, 2026
Enrollment
7 (actual)
Sites
3

Conditions

As the registry lists them; a condition with its own page is linked.

neurogenic detrusor overactivity