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.
NCT ID: NCT01638000
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1887 participants
INTERVENTIONAL
2012-06-12
2013-04-24
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mirabegron 50 mg
Participants who received mirabegron 50 mg once daily for 12 weeks.
Mirabegron
oral tablet
Solifenacin 5 mg
Participants who received solifenacin 5 mg once daily for 12 weeks.
Solifenacin succinate
oral tablet
Interventions
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Mirabegron
oral tablet
Solifenacin succinate
oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
* Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit
Exclusion Criteria
* Subject has neurogenic bladder
* Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
* Subject has an indwelling catheter or practices intermittent self-catheterization
* Subject has diabetic neuropathy
* Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
* The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
* Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
* Subject has moderate to severe hepatic impairment
* Subject has severe renal impairment or end stage renal disease
* Subject has severe uncontrolled hypertension
* Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
* Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
* Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
* Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
* Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
* Subject's last antimuscarinic treatment was solifenacin
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Site: 37406
Yerevan, , Armenia
Site: 37404
Yerevan, , Armenia
Site: 37403
Yerevan, , Armenia
Site: 37401
Yerevan, , Armenia
Site: 37402
Yerevan, , Armenia
Site: 43006
Baden, , Austria
Site: 43014
Graz, , Austria
Site: 43015
Innsbruck, , Austria
Site: 43013
Linz, , Austria
Site: 43005
Oberwart, , Austria
Site: 43011
Vienna, , Austria
Site: 43002
Vienna, , Austria
Site: 43003
Wels, , Austria
Site: 37502
Minsk, , Belarus
Site: 37501
Minsk, , Belarus
Site: 37504
Vitebsk, , Belarus
Site: 32006
Brussels, , Belgium
Site: 32008
Deurne, , Belgium
Site: 32001
Edegem, , Belgium
Site: 32004
Ghent, , Belgium
Site: 32007
Leuven, , Belgium
Site: 32005
Liège, , Belgium
Site: 35902
Burgas, , Bulgaria
Site: 35909
Haskovo, , Bulgaria
Site: 35901
Lovech, , Bulgaria
Site: 35905
Plovdiv, , Bulgaria
Site: 35906
Sofia, , Bulgaria
Site: 35908
Sofia, , Bulgaria
Site: 35903
Sofia, , Bulgaria
Site: 10010
Abbotsford, , Canada
Site: 10011
Barrie, , Canada
Site: 10001
Bathurst, , Canada
Site: 10003
Brampton, , Canada
Site: 10005
Brantford, , Canada
Site: 10007
Kingston, , Canada
Site: 10002
Montreal, , Canada
Site: 10009
Sherbrooke, , Canada
Site: 10004
Toronto, , Canada
Site: 10008
Victoria, , Canada
Site: 42004
Bohumín, , Czechia
Site: 42003
Brno, , Czechia
Site: 42001
Hradec Králové, , Czechia
Site: 42002
Jihlava, , Czechia
Site: 42006
Plzen-Lochotin, , Czechia
Site: 42005
Prague, , Czechia
Site: 42008
Prague, , Czechia
Site: 42007
Prague, , Czechia
Site: 45002
Aalborg, , Denmark
Site: 45001
Aarhus N, , Denmark
Site: 45005
Frederiksbjerg, , Denmark
Site: 45004
Hvidovre, , Denmark
Site: 45003
Odense C, , Denmark
Site: 35802
Jyväskylä, , Finland
Site: 35801
Oulu, , Finland
Site: 35804
Tampere, , Finland
Site: 33010
Angers, , France
Site: 33007
Colmar, , France
Site: 33011
Dijon, , France
Site: 33002
Marseille, , France
Site: 33006
Marseille, , France
Site: 33013
Nîmes, , France
Site: 33004
Orléans, , France
Site: 33001
Paris, , France
Site: 33005
Paris, , France
Site: 33003
Rouen, , France
Site: 33014
Suresnes, , France
Site: 33017
Tours, , France
Site: 33015
Valence, , France
Site: 99501
Tbilisi, , Georgia
Site: 99502
Tbilisi, , Georgia
Site: 99503
Tbilisi, , Georgia
Site: 49006
Bad Ems, , Germany
Site: 49009
Halle, , Germany
Site: 30005
Alexandroupoli, , Greece
Site: 30009
Athens, , Greece
Site: 30007
Athens, , Greece
Site: 30001
Athens, , Greece
Site: 30006
Heraklion, , Greece
Site: 30008
Larissa, , Greece
Site: 30004
Pátrai, , Greece
Site: 30010
Thessaloniki, , Greece
Site: 30002
Thessaloniki, , Greece
Site: 36003
Budapest, , Hungary
Site: 36004
Budapest, , Hungary
Site: 36005
Csongrád, , Hungary
Site: 36006
Nyíregyháza, , Hungary
Site: 36001
Salgótarján, , Hungary
Site: 36002
Szekszárd, , Hungary
Site: 35304
Cork, , Ireland
Site: 35302
Dublin, , Ireland
Site: 35306
Dublin, , Ireland
Site: 35301
Dublin, , Ireland
Site: 35303
Tralee, , Ireland
Site: 35305
Waterford, , Ireland
Site: 39001
Avellino, , Italy
Site: 39005
Catanzaro, , Italy
Site: 39003
Cinisello Balsamo, , Italy
Site: 39002
Florence, , Italy
Site: 39008
Milan, , Italy
Site: 39010
Pavia, , Italy
Site: 39006
Perugia, , Italy
Site: 39007
Treviglio, , Italy
Site: 77705
Almaty, , Kazakhstan
Site: 77706
Almaty, , Kazakhstan
Site: 77703
Astana, , Kazakhstan
Site: 77702
Astana, , Kazakhstan
Site: 37103
Liepāja, , Latvia
Site: 37102
Riga, , Latvia
Site: 37101
Riga, , Latvia
Site: 96102
Byblos, , Lebanon
Site: 96103
El Achrafiyé, , Lebanon
Site: 37001
Kaunas, , Lithuania
Site: 37003
Vilnius, , Lithuania
Site: 31010
Amsterdam, , Netherlands
Site: 31005
Eindhoven, , Netherlands
Site: 31004
Enschede, , Netherlands
Site: 31007
Nijmegen, , Netherlands
Site: 31001
Tilburg, , Netherlands
Site: 31008
Utrecht, , Netherlands
Site: 31006
Zwolle, , Netherlands
Site: 47002
Hamar, , Norway
Site: 47005
Trondheim, , Norway
Site: 47001
Tønsberg, , Norway
Site: 48007
Kolbuszowa Dolna, , Poland
Site: 48006
Krakow, , Poland
Site: 48001
Lublin, , Poland
Site: 48004
Piaseczno, , Poland
Site: 48003
Warsaw, , Poland
Site: 48005
Wroclaw, , Poland
Site: 35105
Lisbon, , Portugal
Site: 35104
Lisbon, , Portugal
Site: 35102
Matosinhos Municipality, , Portugal
Site: 35103
Porto, , Portugal
Site: 35101
Setúbal, , Portugal
Site: 70007
Moscow, , Russia
Site: 70001
Moscow, , Russia
Site: 70008
Moscow, , Russia
Site: 70005
Moscow, , Russia
Site: 70006
Moscow, , Russia
Site: 70011
Moscow, , Russia
Site: 70002
Moscow, , Russia
Site: 70003
Moscow, , Russia
Site: 70013
Saint Petersburg, , Russia
Site: 70012
Saint Petersburg, , Russia
Site: 70004
Saint Petersburg, , Russia
Site: 70010
Saint Petersburg, , Russia
Site: 70009
Saint Petersburg, , Russia
Site: 42104
Galanta, , Slovakia
Site: 42106
Martin, , Slovakia
Site: 42103
Piešťany, , Slovakia
Site: 42101
Poprad, , Slovakia
Site: 42105
Trenčín, , Slovakia
Site: 42102
Žilina, , Slovakia
Site: 38603
Ljubljana, , Slovenia
Site: 38604
Ljubljana, , Slovenia
Site: 38601
Maribor, , Slovenia
Site: 38602
Maribor, , Slovenia
Site: 38606
Novo Mesto, , Slovenia
Site: 34001
Barcelona, , Spain
Site: 34002
Barcelona, , Spain
Site: 34009
Bilbao, , Spain
Site: 34010
Donostia / San Sebastian, , Spain
Site: 34004
Madrid, , Spain
Site: 34005
Madrid, , Spain
Site: 34003
Madrid, , Spain
Site: 34011
Mendaro, , Spain
Site: 34013
Murcia, , Spain
Site: 34014
Seville, , Spain
Site: 34012
Valencia, , Spain
Site: 46007
Gothenburg, , Sweden
Site: 46004
Halmstad, , Sweden
Site: 46005
Karlshamn, , Sweden
Site: 46003
Norrtälje, , Sweden
Site: 46002
Stockholm, , Sweden
Site: 46001
Stockholm, , Sweden
Site: 46006
Uppsala, , Sweden
Site: 41001
Frauenfeld, , Switzerland
Site: 41003
Zurich, , Switzerland
Site: 90005
Ankara, , Turkey (Türkiye)
Site: 90003
Ankara, , Turkey (Türkiye)
Site: 90011
Denizli, , Turkey (Türkiye)
Site: 90007
Diyarbakır, , Turkey (Türkiye)
Site: 90004
Istanbul, , Turkey (Türkiye)
Site: 90001
Izmir, , Turkey (Türkiye)
Site: 90008
Izmir, , Turkey (Türkiye)
Site: 90009
Manisa, , Turkey (Türkiye)
Site: 90010
Sivas, , Turkey (Türkiye)
Site: 38007
Chernivtsi, , Ukraine
Site: 38004
Dnipro, , Ukraine
Site: 38001
Kharkiv, , Ukraine
Site: 38002
Kiev, , Ukraine
Site: 38003
Lviv, , Ukraine
Site: 44027
Aberdeen, , United Kingdom
Site: 44029
Birmingham, , United Kingdom
Site: 44025
Cambridge, , United Kingdom
Site: 44030
Chichester, , United Kingdom
Site: 44028
Croydon, , United Kingdom
Site: 44003
Devon, , United Kingdom
Site: 44001
Edgbaston, , United Kingdom
Site: 44011
Glasgow, , United Kingdom
Site: 44023
Harrow, , United Kingdom
Site: 44006
Kent, , United Kingdom
Site: 44012
Leeds, , United Kingdom
Site: 44019
Leicester, , United Kingdom
Site: 44008
Liverpool, , United Kingdom
Site: 44010
London, , United Kingdom
Site: 44017
London, , United Kingdom
Site: 44013
Newcastle upon Tyne, , United Kingdom
Site: 44022
Northwood, , United Kingdom
Site: 44021
Nottingham, , United Kingdom
Site: 44009
Plymouth, , United Kingdom
Site: 44007
Reading, , United Kingdom
Site: 44005
Sheffield, , United Kingdom
Site: 44020
Southampton, , United Kingdom
Site: 44026
Taunton, , United Kingdom
Site: 44024
West Yorkshire, , United Kingdom
Site: 44002
West Yorkshire, , United Kingdom
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2011-005713-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
178-EC-001
Identifier Type: -
Identifier Source: org_study_id
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