Study Details
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
Clinicaltrials.gov ID
Astellas Study ID
905-CL-047
EudraCT ID
2011-000330-11
Condition
Bladder Disease
Phase
Phase 3
Age
5 years - 17 years
Sex
Female & Male
Product
N/A
Type
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
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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