This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder (SYNERGY)

October 4, 2018 updated by: Astellas Pharma Europe B.V.

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3527

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1419
    - Site AR54005 IUBA - Instituto Urologico de Buenos Aires
  - Buenos Aires, Argentina, C1181ACH
    - Site AR54003 Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, C1181ACH
    - Site AR54006 Hospital Italiano de Buenos Aires
  - Ciudad Autónoma Buenos Aires, Argentina, C1120AAT
    - Site AR54001 CDU - Centro de Urología
  - Rosario Provincia De Santa Fe, Argentina, 2000
    - Site AR54004 Instituto de Investigaciones Clnicas Rosario
Australia
- - Ballarat, Australia, 3350
    - Site AU61026 Ballarat Urology
  - Brisbane, Australia, 4152
    - Site AU61022 Brisbane South Clinical Research Centre
  - Broadmeadow, Australia, 2292
    - Site AU61005 Hunter Clinical Research
  - Daw Park, Australia, 5041
    - Site AU61015 Repatriation General Hospital
  - Footscray, Australia, 3011
    - Site AU61025 Western Health
  - Malvern, Australia, 3144
    - Site AU61012 Cabrini Hospital
  - Nambour, Australia, 4560
    - Site AU61010 Nambour General Hospital
  - Parkville, Australia, 3052
    - Site AU61002 The Royal Womens Hospital
  - Perth, Australia, 6009
    - Site AU61004 Keogh Institute for Medical Research
  - Randwick, Australia, 2031
    - Site AU61007 Prince of Wales Hospital
  - Richmond, Australia, 3121
    - Site AU61008 Epworth Healthcare
  - Sherwood, Australia, 4075
    - Site AU61019 AusTrialsSherwood
  - Sydney, Australia, 2000
    - Site AU61017 Healthpac Medical Centre
  - Sydney, Australia, 2031
    - Site AU61021 Royal Hospital for Women
  - Wollongong, Australia, 2522
    - Site AU61011 Illawarra Health and Medical Research Institute
Belgium
- - Gent, Belgium, 9000
    - Site BE32004 Gent University Hospital
  - Leuven, Belgium, 3000
    - Site BE32011 Universitaire Ziekenhuizen Leuven
  - Roeselare, Belgium, 8800
    - Site BE32014 Hart Ziekenhuis
  - Sint-Truiden, Belgium, 3800
    - Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna
Bulgaria
- - Pleven, Bulgaria, 5800
    - Site BG35904 University Hospital (UMHAT) - George Stranski
  - Plovdiv, Bulgaria, 4003
    - Site BG35908 MHAT Plovdiv AD
  - Ruse, Bulgaria, 7002
    - Site BG35902 MHAT Ruse
  - Sofia, Bulgaria, 1431
    - Site BG35905 MHAT Alexandrovska Hospital
  - Sofia, Bulgaria, 1606
    - Site BG35903 MHATEM Pirogov
  - Varna, Bulgaria, 9000
    - Site BG35906 UMHAT Varna
  - Veliko Tarnovo, Bulgaria, 5000
    - Site BG35910 MHAT
Canada
- - Quebec, Canada, G1S 2L6
    - Site CA15025 Clinique RSF Inc.
- Alberta
  - Edmonton, Alberta, Canada, T5H 3V9
    - Site CA15029 Royal Alexandra Hospital
  - Edmonton, Alberta, Canada, T6G 2P4
    - Site CA15035 Glenrose Rehabilitation Hospital
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E1
    - Site CA15033 Prohealth
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 3J8
    - Site CA15008 Private Practice
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - Site CA15001 The Male/Female Health & Research Centre
  - Brampton, Ontario, Canada, L6T 4S5
    - Site CA15006 Bramalea Medical Centre
  - Brantford, Ontario, Canada, N3R 4N3
    - Site CA15003 Brantford Urology Research
  - Burlington, Ontario, Canada, L7N 3V2
    - Site CA15042 G. Kenneth Jansz Medicine Professional Corporation
  - Hamilton, Ontario, Canada, L8N 4A6
    - Site CA15044 McMaster Institute of Urology
  - Kingston, Ontario, Canada, K7L 3J7
    - Site CA15031 Centre for Applied Urology Research (CAUR)
  - Kitchener, Ontario, Canada, N2N 2B9
    - Site CA15007 Eunoia2 Incorporated
  - London, Ontario, Canada, N6A 5R9
    - Site CA15034 Oxford/Richmond Medical
  - North York, Ontario, Canada, M2J 1V1
    - Site CA15032 Stanley Flax Medical Prof Corp
  - Toronto, Ontario, Canada, M4N 3M5
    - Site CA15013 Sunnybrook Health Sciences Center
  - Toronto, Ontario, Canada, M4S 1Y2
    - Site CA15004 Primehealth Clinical Research
  - Toronto, Ontario, Canada, M5T 2S8
    - Site CA15002 Toronto Western Hospital
- Quebec
  - Drummondville, Quebec, Canada, J2B 7T1
    - Site CA15026 Rhodin Recherche Clinique
  - Granby, Quebec, Canada
    - Site CA15015 Recherches Cliniques Theradev, Inc.
  - Greenfield Park, Quebec, Canada, J4V 2H3
    - Site CA15021 Urology South Shore Research
  - Laval, Quebec, Canada, H7G 2E6
    - Site CA15030 UroLaval
  - Montreal, Quebec, Canada, H2R1V6
    - Site CA15040 RechercheGCP Research
  - Montreal, Quebec, Canada, H4N 3C5
    - Site CA15020 Diex Research Montreal
  - Point-Claire, Quebec, Canada, H9R 4S3
    - Site CA15010 Ultra Med Research, Inc.
  - Sherbrooke, Quebec, Canada, J1H 1Z1
    - Site CA15027 Diex Research Sherbrooke Inc
  - St-Romuald, Quebec, Canada, G6W 5M6
    - Site CA15039 Pro-recherche
China
- - Beijing, China, 100050
    - Site CN86025 Beijing Friendship Hospital
  - Beijing, China, 100191
    - Site CN86009 Peking University 3rd Hospital
  - Beijing, China, 100730
    - Site CN86013 Beijing Hospital
  - Changchun, China, 130021
    - Site CN86014 The First Hospital Bethune of Jilin University
  - Changsha, China, 410008
    - Site CN86002 Changsha Central Hospital
  - Chengdu, China
    - Site CN86028 General Hospital of Chengdu Military Region of PLA
  - Chongqing, China, 400038
    - Site CN86029 Southwest Hospital (Chongqing)
  - Guangzhou, China, 510180
    - Site CN86016 Guangzhou First People's Hospital
  - Lan Zhou, China, 730030
    - Site CN86027 Second Hospital of Lanzhou University
  - Lanzhou, China
    - Site CN86030 Lanzhou University First Hospital
  - Nanchang, China, 330006
    - Site CN86020 The First Affiliated Hospital of NanChang Univers
  - Nanjing, China, 210006
    - Site CN86023 Nanjing First Hospital
  - Shanghai, China, 200040
    - Site CN86021 HuaDong Hosipital Affiliated to Fudan University
  - Shanghai, China, 200127
    - Site CN86003 Shanghai Renji Hospital
  - Shanghai, China, 200240
    - Site CN86012 The Fifth People's Hospital of Shanghai
  - Suzhou, China, 215004
    - Site CN86011 The Second Affiliated Hospital of Soochow Universi
  - Suzhou, China, 215006
    - Site CN86010 1st Affiliated Hosptital of Suchow University
  - Wenzhou, China, 325000
    - Site CN86026 The First Affiliated Hospital of Wenzhou Medical C
  - Wuhan, China, 430030
    - Site CN86022 Tongji Hospital, Tongji Medical College of Hust
  - Wuhan, China, 430071
    - Site CN86015 Zhongnan Hospital of Wuhan University
  - Wuxi, China, 214023
    - Site CN86018 Wuxi People's Hospital
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.
Colombia
- - Medellin, Colombia
    - Site CO57004 Instituto de Coloproctologia ICO SAS
- Antioquia
  - Medellin, Antioquia, Colombia
    - Site CO57003 Hospital Pablo Tobón Uribe
Czechia
- - Brno, Czechia, 602 00
    - Site CZ42015 Centrum ambulantni gynekologie a primarni pece
  - Hradec Kralove, Czechia, 500 02
    - Site CZ42003 SANUS
  - Hradec Kralove, Czechia, 50005
    - Site CZ42001 Fakultni Nemocnice Hradec Kralove
  - Jihlava, Czechia, 586 33
    - Site CZ42002 Hospital Jihlava
  - Novy Jicin, Czechia, 741 01
    - Site CZ42011 Hospital Novy Jicin
  - Olomouc, Czechia, 772 00
    - Site CZ42010 G-centrum Olomouc S.R.O.
  - Ostrava, Czechia, 700 30
    - Site CZ42014 Private Practice
  - Plzen, Czechia, 301 00
    - Site CZ42005 Research Site s.r.o.
  - Praha 4, Czechia, 140 00
    - Site CZ42007 Uro-Santé/Nová Brumlovka
  - Sternberk, Czechia, 78501
    - Site CZ42013 Urology Clinic
  - Uherske Hradiste, Czechia, 686 08
    - Site CZ42009 Hospital Uherské Hradiště a.s.
  - Usti nad Labem, Czechia, 40001
    - Site CZ42006 Private Practice
Denmark
- - Aalborg, Denmark, 9000
    - Site DK45012 Aalborg Sygehus Nord
  - Aarhus, Denmark, 8200
    - Site DK45013 University Hospital of Aarhus, Skejby
Estonia
- - Parnu, Estonia, 80010
    - Site EE37201 Parnu Hospital
  - Tallinn, Estonia, 10617
    - Site EE37205 West Tallinn Central Hospital
  - Tartu, Estonia, 51014
    - Site EE37202 Tartu University Hospital
Finland
- - Kouvola, Finland, 45200
    - Site FI35801 Kouvolan Lääkäriasema
  - Oulu, Finland, 90029
    - Site FI35803 Oulu University Hospital
  - Vantaa, Finland, 01400
    - Site FI35802 Meilahti Hospital
France
- - Colmar Cedex, France, 68024
    - Site FR33007 Centre Hospitalier Louis Pasteur
  - Dijon, France, 21079
    - Site FR33010 CHU Hopital du Bocage
  - Nantes Cedex 1, France, 44035
    - Site FR33008 CHU Nantes
  - Nimes Cedex, France, 30029
    - Site FR33002 CHU Carémeau
  - Paris, France, 75475
    - Site FR33013 Hopital Saint Louis
  - Paris Cedex 20, France, 75970
    - Site FR33001 Hopital Tenon
  - Paris Cedex 20, France, 75970
    - Site FR33024 Hopital Tenon
  - Pierre Benite Cedex, France, 69495
    - Site FR33011 Centre Hospitalier Lyon Sud
  - Suresnes, France, 92151
    - Site FR33012 Hopital Foch
  - Tours Cedex 9, France, 37044
    - Site FR33005 Hopital Bretonneau
Germany
- - Bad Ems, Germany, 56130
    - Site DE49008 Private Practice
  - Bergisch Gladbach, Germany, 51427
    - Site DE49031 Urologisches Zentrum Refrath
  - Bonn, Germany, 53217
    - Site DE49033 Universitsy Clinic Bonn
  - Duisburg, Germany, 47051
    - Site DE49002 Private Practice
  - Duisburg, Germany, 47179
    - Site DE49032 Urologicum Duisburg
  - Ganderkesee, Germany, 27777
    - Site DE49010 Private Practice
  - Halle (Saale), Germany, 06132
    - Site DE49011 Private Practice
  - Leipzig, Germany, 04105
    - Site DE49013 Private Practice
  - Lutherstadt Eisleben, Germany, 6295
    - Site DE49003 Private Practice
  - Munich, Germany, 81377
    - Site DE49034 LMU Muenchen
  - Neustadt I. Sachsen, Germany, 1844
    - Site DE49001 Private Practice
  - Rostock, Germany, 18107
    - Site DE49026 Zentrum fuer Onkologie und Urologie Rostock
  - Sangerhausen, Germany, 6526
    - Site DE49014 Private Practice
Greece
- - Athens, Greece, 115 28
    - Site GR30009 Aretaieio/Maginio
Hong Kong
- - Hong Kong, Hong Kong
    - Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital
  - Kowloon, Hong Kong
    - Site HK85201 Kwong Wah Hospital
  - Shatin, Hong Kong, 30-32
    - Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital
Hungary
- - Csongrád, Hungary, 6640
    - Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft
  - Kecskemet, Hungary, 6000
    - Site HU36007 Mediroyal Prevention Center
  - Pecs, Hungary, 7621
    - Site HU36005 Uro-clin Ltd
  - Sopron, Hungary, H-9400
    - Site HU36013 Sopron Erzsébet Hospital
  - Szentes, Hungary, 6600
    - Site HU36001 Donatella 99BT
  - Veszprém, Hungary, 8200
    - Site HU36012 Veszprém County Cholnoky Ferenc Hospital
Italy
- - Ancona, Italy, 60126
    - Site IT39022 Azienda Ospedale Umberto I (Ancona)
  - Avellino, Italy, 83100
    - Site IT39007 Azienda Ospedaliera San Giuseppe Moscati
  - Latina, Italy, 4100
    - Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza
  - Milan, Italy, 20132
    - Site IT39003 Ospedale San Raffaele
  - Milano, Italy, 20132
    - Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia
Korea, Republic of
- - Bucheon-Si, Korea, Republic of, 420-767
    - Site KR82014 Soon Chun Hyang University Hospital
  - Busan, Korea, Republic of, 602-715
    - Site KR82006 Dong-A University Medical Center
  - Busan, Korea, Republic of, 602-739
    - Site KR82016 Pusan National University Hospital
  - Cheongju-si, Korea, Republic of, 361-711
    - Site KR82024 Chungbuk National University Hospital
  - Daegu, Korea, Republic of, 700-421
    - Site KR82032 Kyungpook National University Hospital
  - Daegu, Korea, Republic of, 705-717
    - Site KR82005 Yeungnam University Hospital
  - Daegu, Korea, Republic of, 705-718
    - Site KR82029 Daegu Catholic Univ. Medical Center
  - Daejeon, Korea, Republic of, 301-721
    - Site KR82019 Chungnam National University Hospital
  - Daejeon, Korea, Republic of, 302-799
    - Site KR82011 Eulji University Hospital
  - Gwangju, Korea, Republic of, 501757
    - Site KR82031 Chonnam National University Hospital
  - Iksan -Si, Korea, Republic of, 570-711
    - Site KR82009 Wonkwang University Hospital
  - Incheon, Korea, Republic of, 405760
    - Site KR82023 Gachon University Gil Hospital
  - Jeonju-si, Korea, Republic of, 561-712
    - Site KR82010 Chonbuk National University Hospital
  - Seongnam-si, Korea, Republic of, 463-707
    - Site KR82025 Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 100-380
    - Site KR82021 Cheil General Hospital & Women's Healthcare Center
  - Seoul, Korea, Republic of, 110-744
    - Site KR82020 Seoul National University Hospital
  - Seoul, Korea, Republic of, 120-752
    - Site KR82030 Severance Hospital
  - Seoul, Korea, Republic of, 134-701
    - Site KR82013 Hallym University Kangdong Sacred Heart Hospital
  - Seoul, Korea, Republic of, 134-872
    - Site KR82017 Kyung Hee University Medical Center
  - Seoul, Korea, Republic of, 135-710
    - Site KR82002 Samsung Medical Center
  - Seoul, Korea, Republic of, 135-720
    - Site KR82008 Gangnam Severance Hospital
  - Seoul, Korea, Republic of, 136-075
    - Site KR82015 Korea University Medical Center
  - Seoul, Korea, Republic of, 137-040
    - Site KR82001 Seoul Saint Mary's Hospital
  - Seoul, Korea, Republic of, 138-736
    - Site KR82003 Asan Medical Center
  - Seoul, Korea, Republic of, 143-729
    - Site KR82012 Konkuk University Medical Center
  - Suwon-si, Korea, Republic of, 443-721
    - Site KR82004 Ajou University Hospital
Latvia
- - Liepaja, Latvia, LV-3401
    - Site LV37102 Private Practice
  - Olaine, Latvia, LV-2114
    - Site LV37103 Health Centre "Olaine"
  - Riga, Latvia, 1002
    - Site LV37105 P.Stradins Clinical University Hospital
Lithuania
- - Kaunas, Lithuania, 47144
    - Site LT37008 Kaunas 2nd Clinical Hospital
  - Kaunas, Lithuania, 50009
    - Site LT37004 KHospital of Lithuanian University of Health Science
  - Kaunas, Lithuania
    - Site LT37011 Saules Family Medicine Centre
  - Klaipeda, Lithuania, LT-92288
    - Site LT37012 Klaipeda University Hospital
  - Vilnius, Lithuania, 10207
    - Site LT37005 Public Institution Vilnius City University Hospital
  - Vilnius, Lithuania, 10207
    - Site LT37010 Public Institution Vilnius City University Hospital
  - Vilnius, Lithuania, LT-01118
    - Site LT37003 Family Medical Centre Seimos gydytojas
  - Vilnius, Lithuania, LT-08661
    - Site LT37007 Vilnius University Hospital Santariskiu Klinikos
  - Vilnius, Lithuania, LT-09108
    - Site LT37009 Clinics Privatus gydytojas
Malaysia
- - Georgetown, Malaysia, 10990
    - Site MY60006 Hospital Pulau Pinang
  - Kuala Lumpur, Malaysia, 50586
    - Site MY60001 Hospital Kuala Lumpur
  - Kuala Lumpur, Malaysia, 50603
    - Site MY60004 University Malaya Medical Centre
  - Kuala Lumpur, Malaysia, 56000
    - Site MY60005 Universiti Kebangsaan Malaysia Medical Centre
  - Kuching, Malaysia, 93586
    - Site MY60003 Hospital Ummum Sarawak
  - Petaling Jaya, Malaysia, 47500
    - Site MY60002 Sime Darby Medical Centre
Mexico
- - Durango, Mexico, 34000
    - Site MX52004 Consultorio de Especialidad en Urologia
  - Guadalajara, Mexico, 45040
    - Site MX52001 Centro de Investigacin Basica y Clnica
  - Mexico City, Mexico, 6700
    - Site MX52003 Clinstile, Sociedad Anonima de Capital Variable
  - Monterrey, Mexico, 64000
    - Site MX52002 Accelerium Clinical Research/ Hospital San Jorge
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Site NL31002 Academic Medical Center (AMC)
  - Enschede, Netherlands, 7513ER
    - Site NL31006 Medisch Spectrum Twente
  - Nijmegen, Netherlands, 6532 SZ
    - Site NL31005 Canisius-Wilhelmina Ziekenhuis
  - Sneek, Netherlands, 8601 ZK
    - Site NL31010 Antonius Ziekenhuis Sneek
  - Utrecht, Netherlands, 3584 CX
    - Site NL31001 University Medical Centre Utrecht
New Zealand
- - Auckland, New Zealand, 1541
    - Site NZ64004 John A Tuckey Ltd Ascot Central
  - Christchurch, New Zealand, 8014
    - Site NZ64001 Canterbury Urology Research Trust
  - Hamilton, New Zealand, 3204
    - Site NZ64005 Waikato Urology Research Limited
  - Nelson, New Zealand, 7010
    - Site NZ64002 Roundhay Medical Centre
  - Tauranga, New Zealand, 3140
    - Site NZ64003 Tauranga Urology Research Ltd
  - Whangarei, New Zealand
    - Site NZ64006 Cardinal Point Specialist Centre
Norway
- - Hamar, Norway, 2317
    - Site NO47006 M3 Helse AS
  - Lierskogen, Norway, 3420
    - Site NO47008 Norsk Helseklinikk (Heiaklinikken)
  - Ålesund, Norway, 6003
    - Site NO47007 Medi3 Clinic AS, Ålesund
Peru
- - Lima, Peru, 33
    - Site PE51001 Instituto de Ginecologia y Reproduccion
  - Lima, Peru, 41
    - Site PE51002 Clinica San Borja
  - Lima, Peru
    - Site PE51004 Clinica San Pablo
  - Lima, Peru
    - Site PE51005 Hospital Nacional Hipolito Unanue
- Lima
  - La Victoria, Lima, Peru, 13
    - Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud
  - San Isidro, Lima, Peru, 27
    - Site PE51007 Clínica Anglo Americana
Philippines
- - Bacolod City, Philippines, 6100
    - Site PH63008 Dr. Pablo O. Torre Memorial Hospital
  - Davao City, Philippines, 8000
    - Site PH63005 Davao Doctor's Hospital
  - Davao City, Philippines, 8000
    - Site PH63010 Davao Doctor's Hospital
  - Manila, Philippines, 1008
    - Site PH63003 University of Santo Tomas Hospital (USTH)
  - Manila, Philippines, 1008
    - Site PH63009 Chinese General Hospital and Medical Center
  - Quezon City, Philippines, 1101
    - Site PH63004 East Avenue Medical Center
Poland
- - Bialystok, Poland, 15-351
    - Site PL48018 Gastromed
  - Chorzow, Poland, 41-500
    - Site PL48013 Urovita Ltd.
  - Gdynia, Poland, 81-384
    - Site PL48014 Synexus Polska
  - Lodz, Poland, 90-302
    - Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne
  - Lublin, Poland, 20-632
    - Site PL48010 Nzoz Novita
  - Myslowice, Poland, 41-400
    - Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.
  - Opole, Poland, 45-086
    - Site PL48016 Prywatny Gabinet Urologiczny
  - Piaseczno, Poland, 05-500
    - Site PL48005 HEUREKA Hanna Szalecka
  - Warsaw, Poland, 00-909
    - Site PL48012 Military Institute of Medicine
  - Warsaw, Poland, 02-507
    - Site PL48003 CSKMSW
  - Warszawa, Poland, 02-929
    - Site PL48001 Specjalistyczny Gabinet Lekarski
  - Wrocław, Poland, 50-088
    - Site PL48019 Synexus Polska sp. z o. o.
Romania
- - Brasov, Romania, 500152
    - Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov
  - Bucuresti, Romania, 42122
    - Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan
  - Bucuresti, Romania, 50659
    - Site RO40001 Spiatlul Clinic Th. Burghele
  - Bucuresti, Romania, 50659
    - Site RO40005 Spiatlul Clinic Th. Burghele
  - Cluj-Napoca, Romania, 400046
    - Site RO40014 E-URO Cabinet
  - Iasi, Romania, 700503
    - Site RO40007 Spital Clinic
  - Sibiu, Romania, 550245
    - Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu
  - Timisoara, Romania, 300736
    - Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara
Russian Federation
- - Kazan, Russian Federation, 420097
    - Site RU70015 LLC Clinical Research Medical Complex
  - Penza, Russian Federation, 440026
    - Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko
  - Saint Petersburg, Russian Federation, 194354
    - Site RU70019 City Multidisciplinary Hospital No. 2
  - Saint Petersburg, Russian Federation, 197089
    - Site RU70002 Pavlov St. Petersburg State Medical University
  - Saint Petersburg, Russian Federation, 198103
    - Site RU70022 St. Petersburg State Public Health Institution
  - St. Petersburg, Russian Federation, 199178
    - Site RU70014 OOO Hospital Orkli
  - Ufa, Russian Federation, 450096
    - Site RU70018 Bashkirsky State Medical University of Roszdrav
Singapore
- - Singapore, Singapore, 119074
    - Site SG65001 National University Hospital
  - Singapore, Singapore, 169608
    - Site SG65002 Singapore General Hospital
  - Singapore, Singapore, 229899
    - Site SG65003 KK Women's and Children's Hospital
Slovakia
- - Bratislava, Slovakia, 82101
    - Site SK42105 Ruzinovska poliklinika a.s.
  - Kosice, Slovakia, 4001
    - Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.
  - Kosice, Slovakia, 4013
    - Site SK42101 Andrologicka a Urologicka Ambulancia
  - Nitra, Slovakia, 949 01
    - Site SK42103 UroExam s.r.o.
  - Poprad, Slovakia, 058 01
    - Site SK42108 BrenCare, s. r. o.
  - Presov, Slovakia, 8001
    - Site SK42104 Urology Outpatient Department
  - Trencin, Slovakia, 911 01
    - Site SK42106 Private Urological Care Center
  - Trencin, Slovakia, 91101
    - Site SK42102 CeGys, s.r.o.
Slovenia
- - Murska Sobota, Slovenia, 9000
    - Site SI38604 General Hospital Murska Sobota
  - Novo Mesto, Slovenia, 8000
    - Site SI38602 General Hospital Novo Mesto
South Africa
- - Cape Town, South Africa, 7925
    - Site ZA27005 Grootte Schuur Hospital
  - Centurion, South Africa, 0157
    - Site ZA27001 Private Practice
  - Durban, South Africa, 4001
    - Site ZA27006 Parklands Hospital
  - Meyerspark, South Africa, 184
    - Site ZA27013 Synexus Clinical Research SA (Pty) Ltd
  - Paarl, South Africa, 7646
    - Site ZA27007 Paarl Medical Centre
  - Roodepoort, South Africa, 1709
    - Site ZA27002 Mayo Clinic
Spain
- - Coslada, Spain, 28822
    - Site ES34010 Hospital del Henares
  - Esplugues De Llobregat-Barcelo, Spain, 08950
    - Site ES34024 Hospital San Juan de Dios
  - Getafe (Madrid), Spain, 28905
    - Site ES34001 Hospital Universitario de Getafe
  - Madrid, Spain, 28016
    - Site ES34006 Hospital San Rafael
  - Madrid, Spain, 28031
    - Site ES34004 Hospital Infanta Leonor
  - Madrid, Spain, 28044
    - Site ES34015 Hospital 12 de Octubre
  - Madrid, Spain, 28046
    - Site ES34009 Hospital Universitario La Paz
  - Madrid, Spain, 28942
    - Site ES34005 Hospital de Fuenlabrada
  - Sevilla, Spain, 41001
    - Site ES34003 Hospital Universitario Nuestra Señora de Valme
  - Sevilla, Spain, 41013
    - Site ES34007 Hospital Virgen del Rocio
  - Valencia, Spain, 46026
    - Site ES34002 H. U. Politecnico La Fe
Sweden
- - Boras, Sweden, 506 30
    - Site SE46007 Ladulaas Clinical Studies
  - Helsingborg, Sweden, 252 20
    - Site SE46025 Pharmasite
  - Malmö, Sweden, 211 52
    - Site SE46005 Center för Läkemedelsstudier
  - Stockholm, Sweden, 111 57
    - Site SE46016 Citydiabetes - Stockholm
  - Stockholm, Sweden, 115 22
    - Site SE46008 Bragée Medect AB
  - Stockholm, Sweden, 141 86
    - Site SE46012 Karolinska University Hospital Huddinge
  - Stockholm, Sweden, 182 88
    - Site SE46003 Danderyds Hospital
  - Uppsala, Sweden, 753 35
    - Site SE46009 Encia AB, Uppsala Hälsomottagning
  - Vällingby, Sweden, 162 68
    - Site SE46017 S3 Clinical Research Centers
Taiwan
- - Taichung, Taiwan, 40705
    - Site TW88605 Taichung Veteran General Hospital
  - Taichung, Taiwan, 407
    - Site TW88611 Chung Shan Medical University Hospital
  - Tainan, Taiwan, 710
    - Site TW88612 Chi Mei Medical Center, Yong Kang
  - Taipei, Taiwan, 114
    - Site TW88614 Tri-Service General Hospital
Thailand
- - Bangkok, Thailand, 10330
    - Site TH66002 Chulalongkorn Hospital
  - Bangkok, Thailand, 10400
    - Site TH66008 Phramongkutklao Hospital
  - Bangkok, Thailand, 10700
    - Site TH66005 Siriraj Hospital
  - Chiang Mai, Thailand, 50200
    - Site TH66010 Maharaj Nakorm Chiangmai Hosp
  - Hat Yai, Thailand, 90110
    - Site TH66006 Songklanagarind Hospital, Prince of Songkla University
  - Khon Kaen, Thailand, 40002
    - Site TH66009 Srinagarind Hospital
  - Pathum Thani, Thailand, 12120
    - Site TH66007 Thammasat University Hospital
  - Ratchathewi, Thailand, 10400
    - Site TH66011 Ramathibodi Hospital
Turkey
- - Ankara, Turkey, 06100
    - Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital
  - Bursa, Turkey, 16059
    - Site TR90013 Uludag University Faculty of Medicine
  - Denizli, Turkey, 20070
    - Site TR90001 Pamukkale University Faculty of Medicine
  - Istanbul, Turkey, 34381
    - Site TR90017 Bilim University Sisli Florence Nightingale Hospital
Ukraine
- - Chernigov, Ukraine, 14034
    - Site UA38002 City Hospital No 2
  - Chernivtsi, Ukraine, 58000
    - Site UA38015 Regional Municipal Institution, Urology Department
  - Dnipropetrovsk, Ukraine, 49005
    - Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov
  - Kharkiv, Ukraine, 61037
    - Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology
  - Kiev, Ukraine, 02232
    - Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric
  - Kyiv, Ukraine, 02660
    - Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3
  - Kyiv, Ukraine, 04053
    - Site UA38010 Academy of Medical Sciences of Ukraine
  - Uzhorod, Ukraine, 88000
    - Site UA38014 Uzhgorod City Polyclinic
  - Vinnytsya, Ukraine, 21010
    - Site UA38004 Vinnitsa Endocrinology Dispens
  - Zaporizhzhya, Ukraine, 69600
    - Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic
United Kingdom
- - Crewe, United Kingdom, CW1 4QJ
    - Site GB44003 Leighton Hospital
  - Gillingham, United Kingdom, ME7 5WY
    - Site GB44021 Medway Hospital
  - Harrow, United Kingdom, HA1 3UJ
    - Site GB44005 North West London Hosp Menopause Clinic
  - Leeds, United Kingdom, LS7 9TF
    - Site GB44024 St James's University Hospital
  - London, United Kingdom, SE5 9RS
    - Site GB44025 Kings College Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Site GB44006 Derriford Hospital
  - Reading, United Kingdom, RG1 5AN
    - Site GB44022 The Royal Berkshire Hospital
  - Sheffield, United Kingdom, S10 2JF
    - Site GB44001 Royal Hallamshire Hospital
- Watfort
  - Garston, Watfort, United Kingdom, WD25 0EA
    - Site GB44009 Sheepcot Medical Centre
United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Site US10049 Coastal Clinical Research, Inc.
  - Mobile, Alabama, United States, 36608
    - Site US10112 TFI, LLC
- Arizona
  - Chandler, Arizona, United States, 85224
    - Site US10104 Clinical Research Advantage, Inc.
  - Phoenix, Arizona, United States, 85051
    - Site US10021 Beach Clinical Studies
- California
  - Anaheim, California, United States, 92801
    - Site US10122 Orange County Research Institute
  - Cerritos, California, United States, 90703
    - Site US10098 Skyline Research
  - Glendora, California, United States, 91741
    - Site US10539 Citrus Valley Medical Research
  - Hawaiian Gardens, California, United States, 90716
    - Site US10082 American Clinical Trials
  - Los Angeles, California, United States, 90017
    - Site US10132 Axis Clinical Trials
  - Los Angeles, California, United States, 90036
    - Site US10133 Axis Clinical Trials
  - Palo Alto, California, United States, 93404
    - Site US10536 Stanford School of Medicine
  - Paramount, California, United States, 90723
    - Site US10149 Bayview Research Group
  - Sacramento, California, United States, 95817
    - Site US10559 UC Davis Medical Center
  - San Diego, California, United States, 92120
    - Site US10003 San Diego Clinical Trials
  - San Diego, California, United States, 92120
    - Site US10545 San Diego Institute for Sexual Medicine
  - Tarzana, California, United States, 91356
    - Site US10106 West Coast Clinical Research
  - Valley Village, California, United States, 91607
    - Site US10595 Bayview Research Group
- Colorado
  - Denver, Colorado, United States, 80211
    - Site US10034 Urology Center of Colorado
  - Lakewood, Colorado, United States, 80228
    - Site US10070 Physicians' Research Options/Red Rocks OB/GYN
  - Wheat Ridge, Colorado, United States, 80033
    - Site US10053 Western Clinical Research, Inc.
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Site US10128 Clinical Research Center of CT
  - New Britain, Connecticut, United States, 06052
    - Site US10018 Grove Hill Clinical Research
  - New Haven, Connecticut, United States, 06510
    - Site US10170 Yale - New Haven Hospital West Haven VAMC
  - Waterbury, Connecticut, United States, 06708
    - Site US10123 Chase Medical Research, LLC
- Florida
  - Bradenton, Florida, United States, 34208
    - Site US10060 Meridien Research
  - Hialeah, Florida, United States, 33012
    - Site US10097 A.G.A. Clinical Trials DBA Neostart Group
  - Hialeah, Florida, United States, 33016
    - Site US10148 Best Quality Research, Inc.
  - Hialeah, Florida, United States, 33016
    - Site US10153 Palmetto Professional Research
  - Hialeah, Florida, United States, 33016
    - Site US10159 Urological Research Network
  - Hialeah, Florida, United States, 33016
    - Site US10534 South Florida Medical Research
  - Homestead, Florida, United States, 33030
    - Site US10535 South Florida Medical Research
  - Jacksonville, Florida, United States, 32216
    - Site US10165 East Coast Institute for Research
  - Jupiter, Florida, United States, 33458
    - Site US10091 Health Awareness
  - New Port Richey, Florida, United States, 34652
    - Site US10150 Suncoast Clinical Research, Inc.
  - Ocala, Florida, United States, 34471
    - Site US10158 Renstar Medical Research
  - Orlando, Florida, United States, 32803
    - Site US10124 Winter Park Urology Associates
  - Orlando, Florida, United States, 32806
    - Site US10134 Compass Research, LLC
  - Pembroke Pines, Florida, United States, 33027
    - Site US10009 South Broward Research
  - Pembroke Pines, Florida, United States, 33028
    - Site US10540 Demaur Clinical Research, INC
  - Plantation, Florida, United States, 33317
    - Site US10554 Private Practice
  - Sarasota, Florida, United States, 34237
    - Site US10095 Florida Urology Specialists
  - Tallahassee, Florida, United States, 32308
    - Site US10010 Southeastern Research Group, Inc
  - Wellington, Florida, United States, 33449
    - Site US10014 Private Practice
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Site US10037 Atlanta Medical Research Institute
  - Roswell, Georgia, United States, 30076
    - Site US10127 Perimeter North Medical Research, Inc.
  - Sandy Springs, Georgia, United States, 30328
    - Site US10120 WR-Mount Vernon Clinical Research
- Kansas
  - Shawnee Mission, Kansas, United States, 66218
    - Site US10024 GTC Research
  - Wichita, Kansas, United States, 67205
    - Site US10078 Heartland Research Associates, LLC
- Louisiana
  - Lake Charles, Louisiana, United States, 70601
    - Site US10088 Centex Studies, Inc.
  - Metairie, Louisiana, United States, 70006
    - Site US10074 Medpharmics, LLC
  - Shreveport, Louisiana, United States, 71106
    - Site US10025 Regional Urology, LLC
- Maryland
  - Glen Burnie, Maryland, United States, 21061
    - Site US10558 Chesapeake Urology Research Associates
  - Owings Mills, Maryland, United States, 21117
    - Site US10560 Chesapeake Urology Research Associates
- Massachusetts
  - Boston, Massachusetts, United States, 02131
    - Site US10282 Boston Clinical Trials
  - Watertown, Massachusetts, United States, 02472
    - Site US10114 Bay State Clinical Trials, Inc.
- Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Site US10152 Female Pelvic Medicine & Urogynecology Institute
- Minnesota
  - Sartell, Minnesota, United States, 56377
    - Site US10542 Adult & Pediatric Urology Group
- Montana
  - Billings, Montana, United States, 59102
    - Site US10110 Montana Health Research Institute, Inc.
  - Missoula, Montana, United States, 59801
    - Site US10154 Montana Medical Research Inc
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Site US10553 Women's Clinic of Lincoln
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Site US10140 IVCTLV
- New Jersey
  - Englewood, New Jersey, United States, 07631
    - Site US10002 Urology Center Research Institute
  - Lawrenceville, New Jersey, United States, 08648
    - Site US10051 AdvancedMed Research
  - Lawrenceville, New Jersey, United States, 86480
    - Site US10047 Lawrence OBGYN Associates
  - Moorestown, New Jersey, United States, 08057
    - Site US10162 Phoenix OB-GYN Associates, LLC
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Site US10011 Albuquerque Clinical Trials, Inc.
  - Albuquerque, New Mexico, United States, 87109
    - Site US10015 Urology Group of New Mexico
- New York
  - Albany, New York, United States, 12205
    - Site US10077 Northeast Urogynecology
  - Brooklyn, New York, United States, 11220
    - Site US10089 Maimonides Medical Center
  - Garden City, New York, United States, 11530
    - Site US10026 AccuMed Research Associates
  - Kingston, New York, United States, 12401
    - Site US10040 Premier Medical Group Of The Hudson Valley
  - New York, New York, United States, 10016
    - Site US10073 Manhattan Medical Research Practice, PLLC
  - New York, New York, United States, 10018
    - Site US10249 New York Clinical Trials
  - New York, New York, United States, 10065
    - Site US10168 Weill Cornell Medical College
  - Newburgh, New York, United States, 12550
    - Site US10126 Premier Medical Group
  - Poughkeepsie, New York, United States, 12601
    - Site US10028 Premier Medical Group of the Hudson Valley
  - Williamsville, New York, United States, 14221
    - Site US10593 Upstate Clinical Research Associates LLC
- North Carolina
  - Concord, North Carolina, United States, 28025
    - Site US10076 Carolina Clinical Trials
  - Raleigh, North Carolina, United States, 27609
    - Site US10129 PMG Research of Raleigh
  - Raleigh, North Carolina, United States, 27612
    - Site US10549 Associated Urologists of North Carolina
  - Winston-Salem, North Carolina, United States, 27103
    - Site US10062 Piedmont Medical Research
- Ohio
  - Cleveland, Ohio, United States, 44122
    - Site US10050 Rapid Medical Research, Inc.
  - Lyndhurst, Ohio, United States, 44124
    - Site US10033 Ohio Clinical Research
  - Wadsworth, Ohio, United States, 44281
    - Site US10067 Family Practice Center of Wadsworth
  - West Chester, Ohio, United States, 45069
    - Site US10551 The Christ Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73112
    - Site US10109 Lynn Health Science Institute
- Oregon
  - Medford, Oregon, United States, 97504
    - Site US10541 Sunstone Medical Research
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004
    - Site US10008 Urologic Consultants of Southeastern Pennsylvania
  - Lancaster, Pennsylvania, United States, 17604
    - Site US10045 Lancaster Urology
  - Philadelphia, Pennsylvania, United States, 19114
    - Site US10017 Philadelphia Clinical Research, LLC
  - Pittsburgh, Pennsylvania, United States, 15213
    - Site US10167 University of Pittsburgh Medical Center
  - Pittsburgh, Pennsylvania, United States, 15236
    - Site US10250 Preferred Primary Care Physicians Inc.
  - Pittsburgh, Pennsylvania, United States, 15243
    - Site US10248 Preferred Primary Care Physicians, Inc
  - Uniontown, Pennsylvania, United States, 15401
    - Site US10063 Preferred Primary Care Physician Research
  - West Reading, Pennsylvania, United States, 19611
    - Site US10012 Advanced Clinical Concepts
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Site US10166 Medical University of South Carolina
  - Greer, South Carolina, United States, 29650
    - Site US10094 University Medical Group
  - Mount Pleasant, South Carolina, United States, 29464
    - Site US10046 Coastal Carolina Research Center
  - Mount Pleasant, South Carolina, United States, 29464
    - Site US10079 PMG Research of Charleston, LLC
  - Myrtle Beach, South Carolina, United States, 29572
    - Site US10117 Carolina Urologic Research Center
  - Simpsonville, South Carolina, United States, 29681
    - Site US10023 Hillcrest Clinical Research, LLC
  - Summerville, South Carolina, United States, 29485
    - Site US10101 Palmetto Clinical Research
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Site US10006 Holston Medical Group
- Texas
  - Austin, Texas, United States, 78745
    - Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc
  - Carrollton, Texas, United States, 75010
    - Site US10066 Texas Urology PA
  - Corpus Christi, Texas, United States, 78414
    - Site US10065 Advanced Research Associates
  - Houston, Texas, United States, 77062
    - Site US10085 Centex Studies, Inc.
  - Houston, Texas, United States, 77074
    - Site US10108 Clinical Trial Network
  - Houston, Texas, United States, 77094
    - Site US10219 Methodist Urology Associates
  - Houston, Texas, United States, 77098
    - Site US10093 Pioneer Research Solutions, Inc.
  - Hurst, Texas, United States, 76054
    - Site US10090 Protenium Clinical Research, LLC
  - San Antonio, Texas, United States, 78229
    - Site US10105 Clinical Trials of Texas
  - San Antonio, Texas, United States, 78229
    - Site US10111 Clinical Trials of Texas
- Utah
  - Sandy, Utah, United States, 84070
    - Site US10092 Physicians' Research Options/Salt Lake Women's Center
- Virginia
  - Richmond, Virginia, United States, 23294
    - Site US10032 National Clinical Research Inc.
  - Virginia Beach, Virginia, United States, 23456
    - Site US10064 The Group for Women
  - Virginia Beach, Virginia, United States, 23462
    - Site US10083 Urology of Virginia, PLLC.
- Washington
  - Burien, Washington, United States, 98166
    - Site US10013 Seattle Urology Research Center
  - Mountlake Terrace, Washington, United States, 98043
    - Site US10004 Integrity Medical Research, LLC
  - Seattle, Washington, United States, 98105
    - Site US10155 Seattle Women's Health, Research, Gynecology
  - Walla Walla, Washington, United States, 99362
    - Site US10135 Walla Walla Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

Subject had significant PVR volume (> 150 mL);
Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
Subject had an indwelling catheter or practices intermittent self catheterization.
Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
Subject had moderate to severe hepatic impairment
Subject had severe renal impairment
Subject had a clinically significant abnormal ECG
Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
Subject had an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1: Solifenacin 5 mg + Mirabegron 25 mg Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Myrbetriq Betanis Betmiga Drug: Solifenacin succinate Oral tablet Other Names: Vesicare YM905 Vesikur Vesitrim Drug: Placebo to match mirabegron Oral tablet
Experimental: 2: Solifenacin 5 mg + Mirabegron 50 mg Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Myrbetriq Betanis Betmiga Drug: Solifenacin succinate Oral tablet Other Names: Vesicare YM905 Vesikur Vesitrim Drug: Placebo to match mirabegron Oral tablet
Placebo Comparator: 3: Placebo Participants who received matching placebo once a day for 12 weeks.	Drug: Placebo to match mirabegron Oral tablet Drug: Placebo to match solifenacin succinate Oral tablet
Active Comparator: 4: Solifenacin 5 mg Participants who received solifenacin 5 mg once a day for 12 weeks.	Drug: Solifenacin succinate Oral tablet Other Names: Vesicare YM905 Vesikur Vesitrim Drug: Placebo to match mirabegron Oral tablet
Active Comparator: 5:Mirabegron 25 mg Participants who received mirabegron 25 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Myrbetriq Betanis Betmiga Drug: Placebo to match mirabegron Oral tablet Drug: Placebo to match solifenacin succinate Oral tablet
Active Comparator: 6: Mirabegron 50 mg Participants who received mirabegron 50 mg once a day for 12 weeks.	Drug: Mirabegron Oral tablet Other Names: YM178 Myrbetriq Betanis Betmiga Drug: Placebo to match mirabegron Oral tablet Drug: Placebo to match solifenacin succinate Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours Time Frame: Baseline and EoT (up to 12 weeks)	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.	Baseline and EoT (up to 12 weeks)
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours Time Frame: Baseline and EoT (up to 12 weeks)	A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.	Baseline and EoT (up to 12 weeks)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Link to results on the Astellas Clinical Study Results website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2013

Primary Completion (Actual)

October 22, 2015

Study Completion (Actual)

October 22, 2015

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (Estimate)

October 31, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

178-CL-101
2012-005735-91 (EudraCT Number)
U1111-1153-9095 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations