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A study to evaluate the pharmacokinetics, safety and tolerability of mirabegron OCAS (Oral Controlled Absorption System) in pediatric subjects with neurogenic detrusor overactivity or overactive bladder

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.
NCT02211846

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-202

EudraCT ID

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

2014-000340-15

Follow Trial

Condition

Bladder Disease, Overactive Bladder Disease, Other

Phase

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

Phase 1

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

Sep 2014 - Sep 2015

Masking

None (Open Label)

Enrollment number

34

A multicentre, open-label, single ascending dose Phase 1 study to evaluate the pharmacokinetics, safety and tolerability of mirabegron OCAS tablets in pediatric subjects from 5 to less than 18 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.

Get More Information

Would you like more information about clinical trial sites that are recruiting participants for A study to evaluate the pharmacokinetics, safety and tolerability of mirabegron OCAS (Oral Controlled Absorption System) in pediatric subjects with neurogenic detrusor overactivity or overactive bladder? Contact us by filling our your information to the right and we’ll respond to you.

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Locations

Site PL48003 Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-952

Site PL48001 Pomnik-Centrum Zdrowia Dziecka

Warsaw, Poland, 04-730

Site RS38010 Mother and Child Health Care

Belgrade, Serbia, 11000

Site BE32003 Gent University Hospital

Gent, Belgium, 9000

Site DK45005 Rigshospitalet

Copenhagen, Denmark, 2100

Site DK45004 Børnelægen i Køge

Koege, Denmark, 4600

Site DK45003 Aalborg Sygehus Nord

Aalborg, Denmark, 9000

Site NO47001 Haukeland Sykehus

Bergen, Norway, 5021

Site DK45001 Uni Hosp of Aarhus, Skejby

Aarhus, Denmark, 8200

Site BE32009 Univ.Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Site BE32011 U.Z. Leuven

Leuven, Belgium, 3000

Site BE32004 AZ Groeninge, Campus Vercruyss

Kortrijk, Belgium, 8500

Site DK45002 Kolding Sygehus

Kolding, Denmark, 6000

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