A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Are Previously Treated With Another Medicine But Were Not Satisfied With That Treatment (BEYOND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01638000
First received: July 9, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine whether an experimental medicine (mirabegron) is as good as a currently approved medicine (solifenacin) in the treatment of patients with overactive bladder who have had previous treatment with antimuscarinics (the main group of medicines for treatment of overactive bladder) but were not satisfied with the symptom relief of their last treatment.


Condition Intervention Phase
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Drug: Mirabegron
Drug: Solifenacin succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in the mean number of micturitions per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects reporting at least one treatment-emergent adverse event of dry mouth, constipation or blurred vision during double-blind treatment period [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes (grade 3 or 4) per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean level of urgency [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of pads used per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturia episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with 50% decrease in mean number of incontinence episodes per 24 hours [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with zero incontinence episodes per 24 hours who were incontinent at baseline [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total Euroqol EQ-5D score (and subscales scores) [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in total OABq score (and subscale score) [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Change from baseline in TS-VAS score and Treatment Satisfaction Likert scale [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 1 to 6 items improvement from baseline in Treatment Satisfaction Likert scale [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with micturition normalization to < 8 micturitions per 24 hours [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in PPBC scores [ Time Frame: Baseline and final visit (up to 12 weeks) ] [ Designated as safety issue: No ]
  • Proportion of subjects with ≥ 1 point improvement from baseline in PPBC [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with major (≥ 2 points) improvement from baseline in PPBC [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 1887
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirabegron Drug: Mirabegron
oral tablet
Other Names:
  • YM178
  • Betanis
  • Myrebtriq
Active Comparator: Solifenacin Drug: Solifenacin succinate
oral tablet
Other Names:
  • Vesicare
  • Vesitrim
  • Vesikur
  • YM905

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638000

  Hide Study Locations
Locations
Armenia
Site: 37401
Yerevan, Armenia, 0078
Site: 37402
Yerevan, Armenia, 0078
Site: 37403
Yerevan, Armenia, 0052
Site: 37404
Yerevan, Armenia, 0014
Site: 37406
Yerevan, Armenia, 0001
Austria
Site: 43006
Baden, Austria, 2500
Site: 43014
Graz, Austria, 9036
Site: 43015
Innsbruck, Austria, 6020
Site: 43013
Linz, Austria, 4020
Site: 43005
Oberwart, Austria, 7400
Site: 43002
Vienna, Austria, 1220
Site: 43011
Vienna, Austria, 1020
Site: 43003
Wels, Austria, 4600
Belarus
Site: 37501
Minsk, Belarus, 223041
Site: 37502
Minsk, Belarus, 220119
Site: 37504
Vitebsk, Belarus, 210037
Belgium
Site: 32006
Brussels, Belgium, 1070
Site: 32008
Deurne, Belgium, 2100
Site: 32001
Edegem, Belgium, 2650
Site: 32004
Gent, Belgium, 9000
Site: 32007
Leuven, Belgium, 3000
Site: 32005
Liege, Belgium
Bulgaria
Site: 35902
Burgas, Bulgaria, 8000
Site: 35909
Haskovo, Bulgaria, 6300
Site: 35901
Lovech, Bulgaria, 5500
Site: 35905
Plovdiv, Bulgaria, 4003
Site: 35903
Sofia, Bulgaria, 1606
Site: 35906
Sofia, Bulgaria, 1431
Site: 35908
Sofia, Bulgaria, 1504
Canada
Site: 10010
Abbotsford, Canada, V2S 3N5
Site: 10011
Barrie, Canada, L4M 7G1
Site: 10001
Bathurst, Canada, E2A 4Z2
Site: 10003
Brampton, Canada, L6T 4S5
Site: 10005
Brantford, Canada, N3R 4N3
Site: 10007
Kingston, Canada, K7L 3J7
Site: 10002
Montreal, Canada, H4N 3C5
Site: 10009
Sherbrooke, Canada, J1H 5N4
Site: 10004
Toronto, Canada, M4N 3M5
Site: 10008
Victoria, Canada, V8V 3N1
Czech Republic
Site: 42004
Bohumin, Czech Republic, 73581
Site: 42003
Brno, Czech Republic, 602 00
Site: 42001
Hradec Kralove, Czech Republic, 500 05
Site: 42002
Jihlava, Czech Republic, 586 33
Site: 42006
Plzen-Lochotin, Czech Republic, 30460
Site: 42008
Prague, Czech Republic, 128 51
Site: 42005
Prague 1, Czech Republic, 110 00
Site: 42007
Prague 4, Czech Republic, 14000
Denmark
Site: 45002
Aalborg, Denmark, 9000
Site: 45001
Aarhus N, Denmark, 8200
Site: 45005
Frederiksbjerg, Denmark, 2000
Site: 45004
Hvidovre, Denmark, 2650
Site: 45003
Odense C, Denmark, 9000
Finland
Site: 35802
Jyvaskyla, Finland, 40620
Site: 35801
Oulu, Finland, 90029
Site: 35804
Tampere, Finland, 33521
France
Site: 33010
Angers, France, 49033
Site: 33007
Colmar Cedex, France, 68024
Site: 33011
Dijon, France, 21000
Site: 33002
Marseille, France, 13285
Site: 33006
Marseille, France, 13385
Site: 33013
Nimes, France, 30029
Site: 33004
Orleans Cedex 2, France, 45067
Site: 33001
Paris Cedex 20, France, 75970
Site: 33005
Paris Cedex 20, France, 75970
Site: 33003
Rouen, France, 76031
Site: 33014
Suresnes Cedex, France, 92151
Site: 33017
Tours, France, 37044
Site: 33015
Valence, France, 26953
Georgia
Site: 99501
Tbilisi, Georgia, 144
Site: 99502
Tbilisi, Georgia, 159
Site: 99503
Tbilisi, Georgia, 159
Germany
Site: 49006
Bad Ems, Germany, 56130
Site: 49009
Halle Saale, Germany, 06132
Greece
Site: 30005
Alexandroupoli, Greece, 68100
Site: 30001
Athens, Greece
Site: 30007
Athens, Greece, 166 73
Site: 30009
Athens, Greece, 115 28
Site: 30006
Herakleion, Greece, 711 10
Site: 30008
Larisa, Greece, 41334
Site: 30004
Patras, Greece, 26500
Site: 30002
Thessaloniki, Greece, 56429
Site: 30010
Thessaloniki, Greece, 546 42
Hungary
Site: 36003
Budapest, Hungary, 1082
Site: 36004
Budapest, Hungary, 1237
Site: 36005
Csongrad, Hungary, H-6640
Site: 36006
Nyiregyhaza, Hungary, H-4400
Site: 36001
Salgotarjan, Hungary, 3100
Site: 36002
Szekszard, Hungary, 7100
Ireland
Site: 35304
Cork, Ireland
Site: 35301
Dublin, Ireland, 9
Site: 35302
Dublin, Ireland, 8
Site: 35306
Dublin, Ireland, 8
Site: 35303
Tralee, Ireland
Site: 35305
Waterford, Ireland
Italy
Site: 39001
Avellino, Italy, 83100
Site: 39005
Catanzaro, Italy, 88100
Site: 39003
Cinisello Balsamo, Italy, 20092
Site: 39002
Florence, Italy, 50139
Site: 39008
Milan, Italy, 20153
Site: 39010
Pavia, Italy, 27100
Site: 39006
Perugia, Italy, 06156
Site: 39007
Treviglio, Italy, 24047
Kazakhstan
Site: 77705
Almaty, Kazakhstan, 050060
Site: 77706
Almaty, Kazakhstan, 50091
Site: 77702
Astana, Kazakhstan, 10000
Site: 77703
Astana, Kazakhstan, 010000
Latvia
Site: 37103
Liepaja, Latvia, LV-3401
Site: 37101
Riga, Latvia, LV-1002
Site: 37102
Riga, Latvia, 1038
Lebanon
Site: 96103
Achrafieh, Lebanon
Site: 96102
Jbeil, Lebanon
Lithuania
Site: 37001
Kaunas, Lithuania, 50219
Site: 37003
Vilnius, Lithuania, LT-01118
Netherlands
Site: 31010
Amsterdam, Netherlands
Site: 31005
Eindhoven, Netherlands, 5623 EJ
Site: 31004
Enschede, Netherlands, 7511 JX
Site: 31007
Nijmegen, Netherlands, 6525 GA
Site: 31001
Tilburg, Netherlands, 5022 GC
Site: 31008
Utrecht, Netherlands, 3584 CX
Site: 31006
Zwolle, Netherlands, 8025 AB
Norway
Site: 47002
Hamar, Norway, 2317
Site: 47001
Tonsberg, Norway, 3103
Site: 47005
Trondheim, Norway, 7006
Poland
Site: 48007
Kolbuszowa Dolna, Poland, 36-100
Site: 48006
Krakow, Poland, 31-315
Site: 48001
Lublin, Poland, 20-632
Site: 48004
Piaseczno, Poland, 05-500
Site: 48003
Warsaw, Poland, 02-929
Site: 48005
Wroclaw, Poland, 01-432
Portugal
Site: 35104
Lisbon, Portugal, 1649-035
Site: 35105
Lisbon, Portugal, 1050-199
Site: 35102
Matosinhos, Portugal, 4454-509
Site: 35103
Porto, Portugal, 4100-180
Site: 35101
Setubal, Portugal, 2910-446
Russian Federation
Site: 70001
Moscow, Russian Federation, 105425
Site: 70002
Moscow, Russian Federation, 119435
Site: 70003
Moscow, Russian Federation, 125206
Site: 70005
Moscow, Russian Federation, 117815
Site: 70006
Moscow, Russian Federation, 117815
Site: 70007
Moscow, Russian Federation, 101000
Site: 70011
Moscow, Russian Federation, 117997
Site: 70008
Moscow, Russian Federation, 115516
Site: 70009
Saint Petersburg, Russian Federation, 199034
Site: 70010
Saint Petersburg, Russian Federation, 198103
Site: 70012
Saint Petersburg, Russian Federation, 196084
Site: 70013
Saint Petersburg, Russian Federation, 194175
Site: 70004
St. Petersburg, Russian Federation, 197089
Slovakia
Site: 42104
Galanta, Slovakia, 924 22
Site: 42106
Martin, Slovakia, 036 59
Site: 42103
Piestany, Slovakia, 92102
Site: 42101
Poprad, Slovakia, 05801
Site: 42105
Trencin, Slovakia, 911 01
Site: 42102
Zilina, Slovakia, 010 01
Slovenia
Site: 38603
Ljubljana, Slovenia, 1000
Site: 38604
Ljubljana, Slovenia, 1000
Site: 38601
Maribor, Slovenia, 2000
Site: 38602
Maribor, Slovenia, 2000
Site: 38606
Novo Mesto, Slovenia, 8000
Spain
Site: 34001
Barcelona, Spain, 080200
Site: 34002
Barcelona, Spain, 08036
Site: 34009
Bilbao, Spain, 48013
Site: 34003
Madrid, Spain, 28049
Site: 34004
Madrid, Spain, 28031
Site: 34005
Madrid, Spain, 28046
Site: 34011
Mendaro, Spain, 20850
Site: 34013
Murcia, Spain, 30008
Site: 34010
San Sebastian, Spain, 20014
Site: 34014
Sevilla, Spain, 41014
Site: 34012
Valencia, Spain, 46026
Sweden
Site: 46007
Gothenburg, Sweden, 413 45
Site: 46004
Halmstad, Sweden, 302 46
Site: 46005
Karlshamn, Sweden, 37435
Site: 46003
Norrtalje, Sweden, 761 29
Site: 46001
Stockholm, Sweden, 14186
Site: 46002
Stockholm, Sweden, 114 46
Site: 46006
Uppsala, Sweden, 753 35
Switzerland
Site: 41001
Frauenfeld, Switzerland, 8501
Site: 41003
Zurich, Switzerland, 8001
Turkey
Site: 90003
Ankara, Turkey, 6100
Site: 90005
Ankara, Turkey, 06500
Site: 90011
Denizli, Turkey, 20070
Site: 90007
Diyarbakir, Turkey, 21080
Site: 90004
Istanbul, Turkey
Site: 90001
Izmir, Turkey, 35100
Site: 90008
Izmir, Turkey, 35340
Site: 90009
Manisa, Turkey, 45010
Site: 90010
Sivas, Turkey, 58140
Ukraine
Site: 38007
Chernivtsi, Ukraine, 58000
Site: 38004
Dnepropetrovsk, Ukraine, 49005
Site: 38001
Kharkov, Ukraine, 61057
Site: 38002
Kiev, Ukraine, 2000
Site: 38003
Lviv, Ukraine, 79044
United Kingdom
Site: 44027
Aberdeen, United Kingdom, AB25 2ZN
Site: 44029
Birmingham, United Kingdom, B15 2TG
Site: 44025
Cambridge, United Kingdom, CB2 2QQ
Site: 44030
Chichester, United Kingdom, PO19 4SE
Site: 44028
Croydon, United Kingdom, CR7 7YE
Site: 44003
Devon, United Kingdom, TQ2 7AA
Site: 44001
Edgbaston, United Kingdom, B15 2TH
Site: 44011
Glasgow, United Kingdom, G11 6NT
Site: 44023
Harrow, United Kingdom, HA 3UJ
Site: 44006
Kent, United Kingdom, ME7 5NY
Site: 44012
Leeds, United Kingdom, LS 9TF
Site: 44019
Leicester, United Kingdom, LE5 4PW
Site: 44008
Liverpool, United Kingdom, L8 7SS
Site: 44010
London, United Kingdom, SW17 0QT
Site: 44017
London, United Kingdom, W2 1NY
Site: 44013
Newcastle upon Tyne, United Kingdom, NE7 7DN
Site: 44022
Northwood, United Kingdom, HA6 2RN
Site: 44021
Nottingham, United Kingdom, NG5 1PB
Site: 44009
Plymouth, United Kingdom, PL6 8DH
Site: 44007
Reading, United Kingdom, RG1 5AN
Site: 44005
Sheffield, United Kingdom, S10 2JF
Site: 44020
Southampton, United Kingdom, SO16 5YA
Site: 44026
Taunton, United Kingdom, TA1 5DA
Site: 44002
West Yorkshire, United Kingdom, WF8 1PL
Site: 44024
West Yorkshire, United Kingdom, BD9 6RJ
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01638000     History of Changes
Other Study ID Numbers: 178-EC-001, 2011-005713-37
Study First Received: July 9, 2012
Last Updated: June 6, 2013
Health Authority: Armenia: Ministry of Health
Austria: Agency for Health and Food Safety
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Egypt: Ministry of Health, Drug Policy and Planning Center
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Jordan: Ethical Committee
Kazakhstan: Ministry of Public Health
Latvia: State Agency of Medicines
Lebanon: Ministry of Public Health
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: The Central Register of Clinical Trials
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Overactive Bladder (OAB)
Urinary incontinence
Urgency incontinence
Frequency
Urgency
Micturition
YM178
Mirabegron
Solifenacin
Vesicare
Vesitrim

Additional relevant MeSH terms:
Urinary Bladder Diseases
Urologic Diseases
Urinary Bladder, Overactive
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014