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A study to assess the long term effect, safety and metabolism of a solifenacin liquid suspension in participants 5 to 18 years of age with neurogenic detrusor overactivity

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.
NCT01565694

Astellas Study ID

The unique identification code given by the study sponsor.

905-CL-047

EudraCT ID

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

2011-000330-11

Follow Trial

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

5 years - 17 years

Sex

Female & Male

Product

N/A

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 2012 - Apr 2016

Masking

None (Open Label)

Enrollment number

76

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

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 RU7002

Moscow, Russian Federation, 123317

Site CA1005

Hamilton, Canada, L8N 3Z5

Site RU7001

Saint Petersburg, Russian Federation, 194100

Site FR3301

Paris, France, 75015

Site BE3201

Gent, Belgium, 9000

Site PL4805

Gdansk, Poland, 80803

Site DE4905

Mainz, Germany, 55101

Site PH6302

Quezon City, Philippines, 1101

Site IN9115

Pune, India, 411040

Site BR5505

Sao Jose do Rio Preto, Brazil, 15090-000

Site HU3602

Miskolc, Hungary, 3526

Site IN9104

Dehradun, India, 248140

Site DE4903

Bonn, Germany, 53105

Site RU7003

Saint Petersburg, Russian Federation, 194100

Site NL3103

Rotterdam, Netherlands, 3015 GJ

Site GB4403

Leeds, United Kingdom, LS17RFJ

Site NL3104

Zwolle, Netherlands, 8011 JW

Site MX5205

Mexico City, Mexico, C.P. 06700

Site TR9002

Izmir, Turkey, 35100

Site BR5506

Curitiba, Brazil, 80240-060

Site PL4802

Wroclaw, Poland, 50-369

Site BR5504

Campinas, Brazil, 13083-887

Site US1010

Cincinnati, United States, 45229-3039

Site US1007

Stanford, United States, 94305

Site BR5507

Campinas, Brazil, 13060-803

Site BR5503

Porto Alegre, Brazil, 90035-903

Site GB4402

Stanmore, United Kingdom, HA7 4LP

Site FR3302

Lille, France, 59037

Site KR8201

Seoul, Republic of Korea, 120752

Site KR8207

Seoul, Republic of Korea, 110744

Site GB4401

Sheffield, United Kingdom, S10 2TH

Site BR5502

Sao Paulo, Brazil, 05403-000

Site PH6301

Manila, Philippines, 1015

Site US1008

Tarrytown, United States, 10591

Site MX5202

Mexico City, Mexico, 04530

Site NL3101

Nijmegen, Netherlands, 6525 GA

Site PL4801

Warszawa, Poland, 04-730

Site TR9005

Istanbul, Turkey, 34890

Site US1015

Albany, United States, 12208

Site DK4501

Aarhus, Denmark, 8200

Site TR9003

Ankara, Turkey, 6100

Site MX5203

Leon, Mexico, 37000

Site TR9004

Kocaeli, Turkey, 41380

Site PL4803

Gdansk, Poland, 80-952

Site DE4901

Marburg, Germany, 35043

Site BR5501

Santo André, São Paulo, Brazil, 09060-650

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