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A study of mirabegron in young children with neurogenic detrusor overactivity

This trial will be recruiting
The study has not started recruiting participants.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT05621616

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-207

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2021-005455-37

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Condition

Bladder Disease

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

6 Months - 3 Years

Sex

Female & Male

Product

mirabegron + solifenacin succinate

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

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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