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.
BEYOND
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
2 other identifiers
interventional
1,887
31 countries
209
Brief Summary
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2012
Shorter than P25 for phase_3
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2012
CompletedFirst Submitted
Initial submission to the registry
July 9, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2013
CompletedResults Posted
Study results publicly available
August 30, 2016
CompletedNovember 21, 2024
October 1, 2024
11 months
July 9, 2012
July 19, 2016
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (46)
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
Baseline and Week 4, Week 8, Week 12
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Week 4, Week 8, Week 12
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Baseline and Week 4, Week 8, Week 12
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Week 4, Week 8, Week 12
- +41 more secondary outcomes
Study Arms (2)
Mirabegron 50 mg
EXPERIMENTALParticipants who received mirabegron 50 mg once daily for 12 weeks.
Solifenacin 5 mg
ACTIVE COMPARATORParticipants who received solifenacin 5 mg once daily for 12 weeks.
Interventions
oral tablet
Eligibility Criteria
You may qualify if:
- Subject is willing and able to complete the micturition diary and questionnaires correctly
- 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
You may not qualify if:
- Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (217)
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
Ghent, 9000, Belgium
Site: 32007
Leuven, 3000, Belgium
Site: 32005
Liège, 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
Bohumín, 73581, Czechia
Site: 42003
Brno, 602 00, Czechia
Site: 42001
Hradec Králové, 500 05, Czechia
Site: 42002
Jihlava, 586 33, Czechia
Site: 42006
Plzen-Lochotin, 30460, Czechia
Site: 42005
Prague, 110 00, Czechia
Site: 42008
Prague, 128 51, Czechia
Site: 42007
Prague, 14000, 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
Jyväskylä, 40620, Finland
Site: 35801
Oulu, 90029, Finland
Site: 35804
Tampere, 33521, Finland
Site: 33010
Angers, 49033, France
Site: 33007
Colmar, 68024, France
Site: 33011
Dijon, 21000, France
Site: 33002
Marseille, 13285, France
Site: 33006
Marseille, 13385, France
Site: 33013
Nîmes, 30029, France
Site: 33004
Orléans, 45067, France
Site: 33001
Paris, 75970, France
Site: 33005
Paris, 75970, France
Site: 33003
Rouen, 76031, France
Site: 33014
Suresnes, 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, 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
Heraklion, 711 10, Greece
Site: 30008
Larissa, 41334, Greece
Site: 30004
Pátrai, 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
Csongrád, H-6640, Hungary
Site: 36006
Nyíregyháza, H-4400, Hungary
Site: 36001
Salgótarján, 3100, Hungary
Site: 36002
Szekszárd, 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
Liepāja, LV-3401, Latvia
Site: 37102
Riga, 1038, Latvia
Site: 37101
Riga, LV-1002, Latvia
Site: 96102
Byblos, Lebanon
Site: 96103
El Achrafiyé, 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: 47005
Trondheim, 7006, Norway
Site: 47001
Tønsberg, 3103, 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 Municipality, 4454-509, Portugal
Site: 35103
Porto, 4100-180, Portugal
Site: 35101
Setúbal, 2910-446, Portugal
Site: 70007
Moscow, 101000, Russia
Site: 70001
Moscow, 105425, Russia
Site: 70008
Moscow, 115516, Russia
Site: 70005
Moscow, 117815, Russia
Site: 70006
Moscow, 117815, Russia
Site: 70011
Moscow, 117997, Russia
Site: 70002
Moscow, 119435, Russia
Site: 70003
Moscow, 125206, Russia
Site: 70013
Saint Petersburg, 194175, Russia
Site: 70012
Saint Petersburg, 196084, Russia
Site: 70004
Saint Petersburg, 197089, Russia
Site: 70010
Saint Petersburg, 198103, Russia
Site: 70009
Saint Petersburg, 199034, Russia
Site: 42104
Galanta, 924 22, Slovakia
Site: 42106
Martin, 036 59, Slovakia
Site: 42103
Piešťany, 92102, Slovakia
Site: 42101
Poprad, 05801, Slovakia
Site: 42105
Trenčín, 911 01, Slovakia
Site: 42102
Žilina, 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: 34010
Donostia / San Sebastian, 20014, 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: 34014
Seville, 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
Norrtälje, 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 (Türkiye)
Site: 90003
Ankara, 6100, Turkey (Türkiye)
Site: 90011
Denizli, 20070, Turkey (Türkiye)
Site: 90007
Diyarbakır, 21080, Turkey (Türkiye)
Site: 90004
Istanbul, Turkey (Türkiye)
Site: 90001
Izmir, 35100, Turkey (Türkiye)
Site: 90008
Izmir, 35340, Turkey (Türkiye)
Site: 90009
Manisa, 45010, Turkey (Türkiye)
Site: 90010
Sivas, 58140, Turkey (Türkiye)
Site: 38007
Chernivtsi, 58000, Ukraine
Site: 38004
Dnipro, 49005, Ukraine
Site: 38001
Kharkiv, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Astellas Pharma Europe Ltd
Study Officials
- STUDY DIRECTOR
Clinical Study Manager
Astellas Pharma Europe Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2012
First Posted
July 11, 2012
Study Start
June 12, 2012
Primary Completion
April 24, 2013
Study Completion
April 24, 2013
Last Updated
November 21, 2024
Results First Posted
August 30, 2016
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- 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.
- 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.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.