Study Details
A study to investigate how effective and safe Solifenacin Succinate Suspension is in treating children/adolescents aged 5 to less than 18 years with symptoms of overactive bladder (OAB) compared to a non-active drug
Clinicaltrials.gov ID
Astellas Study ID
905-CL-076
EudraCT ID
2011-002066-20
Condition
Overactive Bladder Disease
Phase
Phase 3
Age
5 years - 17 years
Sex
Female & Male
Product
N/A
Type
Interventional
Trial Dates
Jun 2012 - Jan 2014
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
189
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of Age with Overactive Bladder (OAB)
Study summary
Study documents
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Locations
Site: 1011
Providence, United States, 02906
Site: 3854
Kharkiv, Ukraine
Site: 5205
Mexico City, Mexico, C.P.06700
Site: 9103
Lucknow, India, 226003
Site: 5504
Campinas, Brazil, 13083-887
Site: 3851
Kyiv, Ukraine, 58001
Site: 3812
Novi Sad, Former Serbia and Montenegro, 21000
Site: 4604
Stockholm, Sweden, 17176
Site: 4403
Leeds, United Kingdom, LS1 3EX
Site: 5507
Campinas, Brazil, 13087-567
Site: 4605
Umea, Sweden, 90185
Site: 3206
Esneux, Belgium, 4130
Site: 3102
Utrecht, Netherlands, 3584 EA
Site: 4806
Poznan, Poland, 61-664
Site: 3209
Antwerp, Belgium, 2650
Site: 8201
Seoul, Republic of Korea, 120752
Site: 6301
Quezon City, Philippines, 1108
Site: 3204
Kortrijk, Belgium, 8500
Site: 9102
Nagpur, India, 440012
Site: 8204
Gwangju, Republic of Korea, 501757
Site: 5501
Santo Andre, Brazil, 090060-650
Site: 1006
Shreveport, United States, 71106
Site: 4803
Gdansk, Poland, 80-952
Site: 5506
Curitiba, Brazil, 80240-060
Site: 3103
Rotterdam, Netherlands, 3015 CE
Site: 5503
Porto Alegre, Brazil, 90035-003
Site: 4401
Sheffield, United Kingdom, S10 2TH
Site: 1005
Hamilton, Canada, L8N 3Z5
Site:8202
Seoul, Republic of Korea, 156707
Site: 4907
Gottingen, Germany, 37075
Site: 3205
Leuven, Belgium, 3000
Site: 4606
Gothenburg, Sweden, 41685
Site: 1001
Quebec, Canada, G1V 4G2
Site: 4905
Mainz, Germany, 55101
Site: 4404
London, United Kingdom, NW1 2BU
Site: 3903
Torino, Italy, 10126
Site: 1008
Tarrytown, United States, 10591
Site: 3302
Lille, France, 59037
Site: 1013
Saint Louis, United States, 63110
Site: 3207
Brussels, Belgium, 1020
Site: 3208
Charleroi, Belgium, 6000
Site: 2701
Johannesburg, South Africa, 1709
Site:8203
Daegu, Republic of Korea, 705717
Site: 4801
Warsaw, Poland, 04-736
Site: 9114
Jaipur, India, 302004
Site: 9001
Ankara, Turkey, 6100
Site: 9109
New Delhi, India, 110001
Site: 7002
Moscow, Russian Federation, 123317
Site: 3210
Leuven, Belgium, 3000
Site: 8206
Incheon, Republic of Korea, 400-711
Site: 5505
Sao Jose do Rio Preto, Brazil, 15090-000
Site: 1009
Durham, United States, 27710
Site: 4804
Lubin, Poland, 20-093
Site: 5502
Sao Paulo, Brazil, 05403-000
Site: 3853
Dnipropetrovsk, Ukraine, 49100
Site: 3810
Belgrade, Former Serbia and Montenegro, 11 000
Site: 3104
Zwolle, Netherlands, 8011 JW
Site: 4906
Frankfurt, Germany, 60435
Site: 9002
Izmir, Turkey, 35100
Site: 1007
Stanford, United States, 94305
Site: 1002
Montreal, Canada, H3H 1P3
Site: 3852
Donetsk, Ukraine, 83045
Site: 4504
Koge, Denmark, 4600
Site: 4503
Aalborg, Denmark, DK-9000
Site: 4601
Jonkoping, Sweden, 55185
Site: 4802
Wroclaw, Poland, 50-369
Site: 9004
Kocaeli, Turkey, 41380
Site:7001
Saint Petersburg, Russian Federation, 194100
Site: 1004
Toronto, Canada, M5G 1X8
Site: 4602
Stockholm, Sweden, 11883
Site: 7003
Saint Petersburg, Russian Federation, 194100
Site: 4805
Gdansk, Poland, 80-803
Site: 4904
Munich, Germany, 80337
Site: 3201
Gent, Belgium, 9000
Site: 4502
Kolding, Denmark, 6000
Site: 4902
Emmendingen, Germany, 79312
Site: 7004
Moscow, Russian Federation, 119991
Site: 4501
Aarhus N, Denmark, 8200
Site: 2703
Cape Town, South Africa, 7700
Site: 5203
Leon, Mexico, 37000
Site: 3811
Belgrade, Former Serbia and Montenegro, 11 000
Site: 4702
Trondheim, Norway, 7030
Site: 9104
Dehradun, India, 248140
Site: 4901
Marburg, Germany, 35043
Site: 9110
Bangalore, India, 560017
Site: 9108
Ahmedabad, India, 380007
Site: 9105
Hyderabad, India, 500018
Site: 4903
Bonn, Germany, 53105
Site: 3902
Firenze, Italy, 50134
Site: 5202
Mexico City, Mexico, 4530
Site: 4701
Bergen, Norway, 5021
Site: 1015
Albany, United States, 12208
Site: 3202
Antwerp, Belgium, 2020
Site: 3101
Nijmegen, Netherlands, 6525 GA
Site: 3203
Gent, Belgium, 9000
Site: 9005
Istanbul, Turkey
Site: 9003
Ankara, Turkey, 6100
Site: 1012
Phoenix, United States, 85032
Site: 3901
Roma, Italy, 165
Site: 4603
Skovde, Sweden, 54185
Site: 7005
Moscow, Russian Federation
Site: 5204
Mexico City, Mexico, 78218
Site: 3301
Paris, France, 75015
Site: 8207
Seoul, Republic of Korea, 110744
Site: 1014
Cincinnati, United States, 45229
Site: 3850
Kiev, Ukraine, 1103