A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
NCT ID: NCT01655069
Last Updated: 2024-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
148 participants
INTERVENTIONAL
2012-10-04
2014-10-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Children Treated with Placebo in 905-CL-076
Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
Solifenacin succinate suspension
Oral suspension
Children Treated with Solifenacin in 905-CL-076
Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.
Solifenacin succinate suspension
Oral suspension
Adolescents Treated with Placebo in 905-CL-076
Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Solifenacin succinate suspension
Oral suspension
Adolescents Treated with Solifenacin in 905-CL-076
Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.
Solifenacin succinate suspension
Oral suspension
Interventions
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Solifenacin succinate suspension
Oral suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076
Exclusion Criteria:
* Subject has failed the exclusion criteria of study 905-CL-076
5 Years
17 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Site: 1006
Shreveport, Louisiana, United States
Site: 3202
Antwerp, , Belgium
Site: 3209
Antwerp, , Belgium
Site: 3208
Charleroi, , Belgium
Site: 3201
Ghent, , Belgium
Site: 3203
Ghent, , Belgium
Site: 3204
Kortrijk, , Belgium
Site: 3205
Leuven, , Belgium
Site: 5507
Campinas, , Brazil
Site: 5506
Curitiba, , Brazil
Site: 1001
Québec, , Canada
Site: 4503
Aalborg, , Denmark
Site: 4501
Aarhus N, , Denmark
Site: 4502
Kolding, , Denmark
Site: 4504
Køge, , Denmark
Site: 5202
Mexico City, , Mexico
Site: 5205
Mexico City, , Mexico
Site: 4701
Bergen, , Norway
Site: 6301
Quezon City, , Philippines
Site: 4805
Gdansk, , Poland
Site: 4803
Gdansk, , Poland
Site: 4804
Lubin, , Poland
Site: 4801
Warsaw, , Poland
Site: 3810
Belgrade, , Serbia and Montenegro
Site: 3812
Novi Sad, , Serbia and Montenegro
Site: 2703
Cape Town, , South Africa
Site: 8203
Daegu, , South Korea
Site: 8206
Incheon, , South Korea
Site: 8207
Seoul, , South Korea
Site: 8202
Seoul, , South Korea
Site: 4606
Gothenburg, , Sweden
Site: 4603
Skövde, , Sweden
Site: 4602
Stockholm, , Sweden
Site: 4605
Umeå, , Sweden
Site: 9001
Ankara, , Turkey (Türkiye)
Site: 9002
Izmir, , Turkey (Türkiye)
Site: 3854
Kharkiv, , Ukraine
Site: 4403
Leeds, , United Kingdom
Site: 4401
Sheffield, , United Kingdom
Countries
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Related Links
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Link to results on EudraCT
Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2011-002047-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-CL-077
Identifier Type: -
Identifier Source: org_study_id
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