Clinical TrialID 5335
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
NCT01638000
Urologic Diseases|Urinary Bladder, Overactive|Urinary Bladder Diseases
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5335
- Evidence Id
- 5335
- Core Evidence Id
- 5335
- Source Clinical Trial Id
- 5321
- Herb2 Clinical Trial Id
- HBCT005321
- Nct Id
- NCT01638000
- Title
- A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Urologic Diseases|Urinary Bladder, Overactive|Urinary Bladder Diseases
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Mirabegron|DRUG: Solifenacin succinate
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 1887
- Outcome Measure
- Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours, A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period., Baseline and final visit (up to Week 12)
- Sponsor Collaborator
- Astellas Pharma Europe Ltd.
- Funded By
- INDUSTRY
- Location
- Site: 37406, Yerevan, 0001, Armenia|Site: 37404, Yerevan, 0014, Armenia|Site: 37403, Yerevan, 0052, Armenia|Site: 37401, Yerevan, 0078, Armenia|Site: 37402, Yerevan, 0078, Armenia|Site: 43006, Baden, 2500, Austria|Site: 43014, Graz, 9036, Austria|Site: 43015, Innsbruck, 6020, Austria|Site: 43013, Linz, 4020, Austria|Site: 43005, Oberwart, 7400, Austria|Site: 43011, Vienna, 1020, Austria|Site: 43002, Vienna, 1220, Austria|Site: 43003, Wels, 4600, Austria|Site: 37502, Minsk, 220119, Belarus|Site: 37501, Minsk, 223041, Belarus|Site: 37504, Vitebsk, 210037, Belarus|Site: 32006, Brussels, 1070, Belgium|Site: 32008, Deurne, 2100, Belgium|Site: 32001, Edegem, 2650, Belgium|Site: 32004, Gent, 9000, Belgium|Site: 32007, Leuven, 3000, Belgium|Site: 32005, Liege, Belgium|Site: 35902, Burgas, 8000, Bulgaria|Site: 35909, Haskovo, 6300, Bulgaria|Site: 35901, Lovech, 5500, Bulgaria|Site: 35905, Plovdiv, 4003, Bulgaria|Site: 35906, Sofia, 1431, Bulgaria|Site: 35908, Sofia, 1504, Bulgaria|Site: 35903, Sofia, 1606, Bulgaria|Site: 10010, Abbotsford, V2S 3N5, Canada|Site: 10011, Barrie, L4M 7G1, Canada|Site: 10001, Bathurst, E2A 4Z2, Canada|Site: 10003, Brampton, L6T 4S5, Canada|Site: 10005, Brantford, N3R 4N3, Canada|Site: 10007, Kingston, K7L 3J7, Canada|Site: 10002, Montreal, H4N 3C5, Canada|Site: 10009, Sherbrooke, J1H 5N4, Canada|Site: 10004, Toronto, M4N 3M5, Canada|Site: 10008, Victoria, V8V 3N1, Canada|Site: 42004, Bohumin, 73581, Czechia|Site: 42003, Brno, 602 00, Czechia|Site: 42001, Hradec Kralove, 500 05, Czechia|Site: 42002, Jihlava, 586 33, Czechia|Site: 42006, Plzen-Lochotin, 30460, Czechia|Site: 42005, Prague 1, 110 00, Czechia|Site: 42007, Prague 4, 14000, Czechia|Site: 42008, Prague, 128 51, Czechia|Site: 45002, Aalborg, 9000, Denmark|Site: 45001, Aarhus N, 8200, Denmark|Site: 45005, Frederiksbjerg, 2000, Denmark|Site: 45004, Hvidovre, 2650, Denmark|Site: 45003, Odense C, 9000, Denmark|Site: 35802, Jyvaskyla, 40620, Finland|Site: 35801, Oulu, 90029, Finland|Site: 35804, Tampere, 33521, Finland|Site: 33010, Angers, 49033, France|Site: 33007, Colmar Cedex, 68024, France|Site: 33011, Dijon, 21000, France|Site: 33002, Marseille, 13285, France|Site: 33006, Marseille, 13385, France|Site: 33013, Nimes, 30029, France|Site: 33004, Orleans Cedex 2, 45067, France|Site: 33001, Paris Cedex 20, 75970, France|Site: 33005, Paris Cedex 20, 75970, France|Site: 33003, Rouen, 76031, France|Site: 33014, Suresnes Cedex, 92151, France|Site: 33017, Tours, 37044, France|Site: 33015, Valence, 26953, France|Site: 99501, Tbilisi, 144, Georgia|Site: 99502, Tbilisi, 159, Georgia|Site: 99503, Tbilisi, 159, Georgia|Site: 49006, Bad Ems, 56130, Germany|Site: 49009, Halle Saale, 06132, Germany|Site: 30005, Alexandroupoli, 68100, Greece|Site: 30009, Athens, 115 28, Greece|Site: 30007, Athens, 166 73, Greece|Site: 30001, Athens, Greece|Site: 30006, Herakleion, 711 10, Greece|Site: 30008, Larisa, 41334, Greece|Site: 30004, Patras, 26500, Greece|Site: 30010, Thessaloniki, 546 42, Greece|Site: 30002, Thessaloniki, 56429, Greece|Site: 36003, Budapest, 1082, Hungary|Site: 36004, Budapest, 1237, Hungary|Site: 36005, Csongrad, H-6640, Hungary|Site: 36006, Nyiregyhaza, H-4400, Hungary|Site: 36001, Salgotarjan, 3100, Hungary|Site: 36002, Szekszard, 7100, Hungary|Site: 35304, Cork, Ireland|Site: 35302, Dublin, 8, Ireland|Site: 35306, Dublin, 8, Ireland|Site: 35301, Dublin, 9, Ireland|Site: 35303, Tralee, Ireland|Site: 35305, Waterford, Ireland|Site: 39001, Avellino, 83100, Italy|Site: 39005, Catanzaro, 88100, Italy|Site: 39003, Cinisello Balsamo, 20092, Italy|Site: 39002, Florence, 50139, Italy|Site: 39008, Milan, 20153, Italy|Site: 39010, Pavia, 27100, Italy|Site: 39006, Perugia, 06156, Italy|Site: 39007, Treviglio, 24047, Italy|Site: 77705, Almaty, 050060, Kazakhstan|Site: 77706, Almaty, 50091, Kazakhstan|Site: 77703, Astana, 010000, Kazakhstan|Site: 77702, Astana, 10000, Kazakhstan|Site: 37103, Liepaja, LV-3401, Latvia|Site: 37102, Riga, 1038, Latvia|Site: 37101, Riga, LV-1002, Latvia|Site: 96103, Achrafieh, Lebanon|Site: 96102, Jbeil, Lebanon|Site: 37001, Kaunas, 50219, Lithuania|Site: 37003, Vilnius, LT-01118, Lithuania|Site: 31010, Amsterdam, Netherlands|Site: 31005, Eindhoven, 5623 EJ, Netherlands|Site: 31004, Enschede, 7511 JX, Netherlands|Site: 31007, Nijmegen, 6525 GA, Netherlands|Site: 31001, Tilburg, 5022 GC, Netherlands|Site: 31008, Utrecht, 3584 CX, Netherlands|Site: 31006, Zwolle, 8025 AB, Netherlands|Site: 47002, Hamar, 2317, Norway|Site: 47001, Tonsberg, 3103, Norway|Site: 47005, Trondheim, 7006, Norway|Site: 48007, Kolbuszowa Dolna, 36-100, Poland|Site: 48006, Krakow, 31-315, Poland|Site: 48001, Lublin, 20-632, Poland|Site: 48004, Piaseczno, 05-500, Poland|Site: 48003, Warsaw, 02-929, Poland|Site: 48005, Wroclaw, 01-432, Poland|Site: 35105, Lisbon, 1050-199, Portugal|Site: 35104, Lisbon, 1649-035, Portugal|Site: 35102, Matosinhos, 4454-509, Portugal|Site: 35103, Porto, 4100-180, Portugal|Site: 35101, Setubal, 2910-446, Portugal|Site: 70007, Moscow, 101000, Russian Federation|Site: 70001, Moscow, 105425, Russian Federation|Site: 70008, Moscow, 115516, Russian Federation|Site: 70005, Moscow, 117815, Russian Federation|Site: 70006, Moscow, 117815, Russian Federation|Site: 70011, Moscow, 117997, Russian Federation|Site: 70002, Moscow, 119435, Russian Federation|Site: 70003, Moscow, 125206, Russian Federation|Site: 70013, Saint Petersburg, 194175, Russian Federation|Site: 70012, Saint Petersburg, 196084, Russian Federation|Site: 70010, Saint Petersburg, 198103, Russian Federation|Site: 70009, Saint Petersburg, 199034, Russian Federation|Site: 70004, St. Petersburg, 197089, Russian Federation|Site: 42104, Galanta, 924 22, Slovakia|Site: 42106, Martin, 036 59, Slovakia|Site: 42103, Piestany, 92102, Slovakia|Site: 42101, Poprad, 05801, Slovakia|Site: 42105, Trencin, 911 01, Slovakia|Site: 42102, Zilina, 010 01, Slovakia|Site: 38603, Ljubljana, 1000, Slovenia|Site: 38604, Ljubljana, 1000, Slovenia|Site: 38601, Maribor, 2000, Slovenia|Site: 38602, Maribor, 2000, Slovenia|Site: 38606, Novo Mesto, 8000, Slovenia|Site: 34001, Barcelona, 080200, Spain|Site: 34002, Barcelona, 08036, Spain|Site: 34009, Bilbao, 48013, Spain|Site: 34004, Madrid, 28031, Spain|Site: 34005, Madrid, 28046, Spain|Site: 34003, Madrid, 28049, Spain|Site: 34011, Mendaro, 20850, Spain|Site: 34013, Murcia, 30008, Spain|Site: 34010, San Sebastian, 20014, Spain|Site: 34014, Sevilla, 41014, Spain|Site: 34012, Valencia, 46026, Spain|Site: 46007, Gothenburg, 413 45, Sweden|Site: 46004, Halmstad, 302 46, Sweden|Site: 46005, Karlshamn, 37435, Sweden|Site: 46003, Norrtalje, 761 29, Sweden|Site: 46002, Stockholm, 114 46, Sweden|Site: 46001, Stockholm, 14186, Sweden|Site: 46006, Uppsala, 753 35, Sweden|Site: 41001, Frauenfeld, 8501, Switzerland|Site: 41003, Zurich, 8001, Switzerland|Site: 90005, Ankara, 06500, Turkey|Site: 90003, Ankara, 6100, Turkey|Site: 90011, Denizli, 20070, Turkey|Site: 90007, Diyarbakir, 21080, Turkey|Site: 90004, Istanbul, Turkey|Site: 90001, Izmir, 35100, Turkey|Site: 90008, Izmir, 35340, Turkey|Site: 90009, Manisa, 45010, Turkey|Site: 90010, Sivas, 58140, Turkey|Site: 38007, Chernivtsi, 58000, Ukraine|Site: 38004, Dnepropetrovsk, 49005, Ukraine|Site: 38001, Kharkov, 61057, Ukraine|Site: 38002, Kiev, 2000, Ukraine|Site: 38003, Lviv, 79044, Ukraine|Site: 44027, Aberdeen, AB25 2ZN, United Kingdom|Site: 44029, Birmingham, B15 2TG, United Kingdom|Site: 44025, Cambridge, CB2 2QQ, United Kingdom|Site: 44030, Chichester, PO19 4SE, United Kingdom|Site: 44028, Croydon, CR7 7YE, United Kingdom|Site: 44003, Devon, TQ2 7AA, United Kingdom|Site: 44001, Edgbaston, B15 2TH, United Kingdom|Site: 44011, Glasgow, G11 6NT, United Kingdom|Site: 44023, Harrow, HA 3UJ, United Kingdom|Site: 44006, Kent, ME7 5NY, United Kingdom|Site: 44012, Leeds, LS 9TF, United Kingdom|Site: 44019, Leicester, LE5 4PW, United Kingdom|Site: 44008, Liverpool, L8 7SS, United Kingdom|Site: 44010, London, SW17 0QT, United Kingdom|Site: 44017, London, W2 1NY, United Kingdom|Site: 44013, Newcastle upon Tyne, NE7 7DN, United Kingdom|Site: 44022, Northwood, HA6 2RN, United Kingdom|Site: 44021, Nottingham, NG5 1PB, United Kingdom|Site: 44009, Plymouth, PL6 8DH, United Kingdom|Site: 44007, Reading, RG1 5AN, United Kingdom|Site: 44005, Sheffield, S10 2JF, United Kingdom|Site: 44020, Southampton, SO16 5YA, United Kingdom|Site: 44026, Taunton, TA1 5DA, United Kingdom|Site: 44024, West Yorkshire, BD9 6RJ, United Kingdom|Site: 44002, West Yorkshire, WF8 1PL, United Kingdom
- Other Id
- 178-EC-001|2011-005713-37
- Start Date
- 2012-06-12
- Primary Completion Date
- 2013-04-24
- Completion Date
- 2013-04-24
- First Posted
- 2012-07-11
- Results First Posted
- 2016-08-30
- Last Update Posted
- 2017-12-18
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01638000
- Title Cn
- Title En
- A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
- Bilingual Status
- semi_complete