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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects from 3 to Less than 12 Years of Age with Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT02526979

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-203

EudraCT ID

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

2015-000700-26

Follow Trial

Condition

Overactive Bladder Disease, Bladder Disease

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

3 years - 11 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

Dec 2015 - Sep 2016

Masking

None (Open Label)

Enrollment number

9

A Multicentre, Open-Label, Single Dose, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron Oral Suspension in Pediatric Subjects from 3 to Less than 12 Years of Age with Neurogenic Detrusor Overactivity (NDO) or Overactive Bladder (OAB)

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site PL48001

Warsaw, Poland, 04-730

Site DK45002

Aalborg, Denmark, 9000

Site DK45001

Aarhus, Denmark, 8200

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