Study Details
Open-label Phase 3 Study with Mirabegron in Children From 3 to Less Than 18 Years of Age with Neurogenic Detrusor Overactivity
Clinicaltrials.gov ID
Astellas Study ID
178-CL-206A
EudraCT ID
2015-002876-25
Condition
Bladder Disease
Phase
Phase 3
Age
3 years - 17 years
Sex
Female & Male
Product
mirabegron + solifenacin succinate
Type
Interventional
Trial Dates
Jun 2016 - May 2019
Masking
None (Open Label)
Enrollment number
91
An Open-label, Baseline-controlled, Multicenter, Phase 3 Dose-titration Study Followed by a Fixed-dose Observation Period to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Children and Adolescents From 3 to Less Than 18 Years of Age with Neurogenic Detrusor Overactivity (NDO) on Clean Intermittent Catheterization (CIC)
Study summary
Study documents
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Locations
Site LV37101
Riga, Latvia, LV-1004
Site DK45001
Aarhus N, Denmark, DK-8200
Site TR90005
Ankara, Turkey, 06100
Site LT37002
Kaunas, Lithuania, LT-50009
Site TR90006
Bursa, Turkey
Site PL48001
Gdansk, Poland, 80803
Site RO40002
Bucuresti, Romania, 021495
Site KR82001
Seoul, Republic of Korea, 03722
Site PH63001
Quezon City, Philippines, 1100
Site CO57002
Cali, Colombia, 760032
Site JO96201
Irbid, Jordan, 22110
Site BE32002
Gent, Belgium, 9000
Site HR38503
Zagreb, Croatia, 10000
Site NO47001
Bergen, Norway, 5021
Site TW88602
Taipei, Taiwan, Province of China, 10002
Site SK42101
Bratislava, Slovakia, 83301
Site PL48003
Gdansk, Poland, 80-952
Site RS38102
Nis, Serbia
Site AU61001
Park Ville VIC, Australia, 3052
Site MY60002
Kuala Lumpur, Malaysia, 50586
Site BE32004
Edegem, Belgium, B-2650
Site MX52002
Mexico City, Mexico, 06700
Site PL48002
Warszawa, Poland, 04-730
Site TW88601
New Taipei City, Taiwan, Province of China, 23142
Site KR82002
Seoul, Republic of Korea, 110744
Site RO40001
Bucuresti, Romania, 22328
Site AU61002
Randwick, Australia, 2031
Site SK42102
Martin, Slovakia, 036 59
Site HR38501
Zagreb, Croatia, 10000
Site BE32001
Gent, Belgium, 9000
Site DK45002
Copenhagen, Denmark, 2100
Site IL97202
Jerusalem, Israel, 91090
Site MY60001
Georgetown, Malaysia, 10990
Site TR90008
Mersin, Turkey, 33343
Site TR90002
Ankara, Turkey, 06100
Site RS38101
Novi Sad, Serbia, 21000
Site LT37001
Vilnius, Lithuania, LT-08406
Site JO96202
Amman, Jordan, 11183