Study Details

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A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04641975

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-204

EudraCT ID

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

2016-001767-37

Follow Trial

Condition

Overactive Bladder Disease, Other

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

5 Years - 17 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

Mar 2021 - Jul 2023

Masking

Double (Participant, Investigator)

Enrollment number

26

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

Study summary

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Locations

Site ML60002

Kuala Lumpur, Malaysia, 50586

Site ML60003

Penang, Malaysia, 10990

Site KR82001

Seoul, Republic of Korea, 5505

Site KR82002

Seoul, Republic of Korea, 3080

Site KR82003

Seoul, Republic of Korea, 3772

Site KR82004

Yangsan-Si, Republic of Korea, 50612

Site NL31001

Deventer, Netherlands, 7416 SE

Site RU70001

Kazan, Russian Federation, 420138

Site TR90001

Bursa, Turkey, 16059

Site CA15006

London, Canada, ON N6A 5W9

Site PH63002

Angeles City, Philippines, 2009

Site PH63004

Cebu City, Philippines, 6000

Site PH63005

Quezon City, Philippines, 1113

Site PH63007

Davao City, Philippines, 8000

Site RU70008

Yekaterinburg, Russian Federation, 620134

Site TR90003

Mersin, Turkey, 33343

Site BE32002

Kortrijk, Belgium, 8500

Site ML60001

Kuala Lumpur, Malaysia, 59100

Site ZA27003

Pretoria, South Africa, 0001

Site UA38007

Ivano-Frankivsk, Ukraine, 76014

Site DE49002

Moenchengladbach, Germany, 41063

Site PH63001

Quezon City, Philippines, 1105

Site RU70004

Moscow, Russian Federation, 117997

Site UA38008

Kharkiv, Ukraine, 61075

Site PL48001

Piaseczno, Poland, 05-500

Site PH63006

Quezon City, Philippines, 1100

Site FR33003

Amiens, France, 80000

Site FR33004

Nice, France, 06200

Site GB44004

Reading, United Kingdom, RG1 5AN

Site BE32005

Gent, Belgium

Site NO47001

Bergen, Norway

Site ES34003

Santiago de Compostela, Spain

Site BE32001

Edegem, Belgium, 2650

Site FR33002

Paris, France, 75015

Site FR33001

Marseille, France, 13005

Site RU70002

Moscow, Russian Federation

Site RU70005

Moscow, Russian Federation

Site BE32004

Antwerpen, Belgium

Site DK45002

Aalborg, Denmark

Site MX52001

Ciudad de Mexico            , Mexico

Site MX52003

Nuevo León                     , Mexico

Site NO47002

Stavanger, Norway

Site NO47003

Lorenskog, Norway

Site GB44003

Newcastle Upon Tyne, United Kingdom

Site GB44005

Nottingham, United Kingdom

Site GB44006

London, United Kingdom

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