Study Details

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.

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01638000

Astellas Study ID

The unique identification code given by the study sponsor.

178-EC-001

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-005713-37

Condition

Bladder Disease, Overactive Bladder Disease

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2012 - Apr 2013

Masking

Double (Participant, Investigator)

Enrollment number

1887

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

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

Get More Information

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Locations

Site: 30006

Herakleion, Greece, 711 10

Site: 96103

Achrafieh, Lebanon

Site: 49010

Hennigsdorf, Germany, 16761

Site: 31005

Eindhoven, Netherlands, 5623 EJ

Site: 38603

Ljubljana, Slovenia, 1000

Site: 39005

Catanzaro, Italy, 88100

Site: 41001

Frauenfeld, Switzerland, 8501

Site: 43014

Graz, Austria, 9036

Site: 49003

Koblenz, Germany, 56068

Site: 40002

Judetul Ilfov, Romania, 077190

Site: 30002

Thessaloniki, Greece, 56429

Site: 34001

Barcelona, Spain, 080200

Site: 70001

Moscow, Russian Federation, 105425

Site: 10001

Bathurst, Canada, E2A 4Z2

Site: 38604

Ljubljana, Slovenia, 1000

Site: 35908

Sofia, Bulgaria, 1504

Site: 44021

Nottingham, United Kingdom, NG5 1PB

Site: 48002

Warsaw, Poland, 00-560

Site: 34002

Barcelona, Spain, 08036

Site: 38606

Novo Mesto, Slovenia, 8000

Site: 44019

Leicester, United Kingdom, LE5 4PW

Site: 40014

Oradea, Romania, 410032

Site: 40008

Craiova, Romania, 200647

Site: 45005

Frederiksbjerg, Denmark, 2000

Site: 44028

Croydon, United Kingdom, CR7 7YE

Site: 38605

Slovenj Gradec, Slovenia

Site: 34008

Pontevedra, Spain

Site: 44017

London, United Kingdom, W2 1NY

Site: 32003

Zottegem, Belgium, 9620

Site: 33007

Colmar Cedex, France, 68024

Site: 70009

Saint Petersburg, Russian Federation, 199034

Site: 37001

Kaunas, Lithuania, 50219

Site: 96203

Irbid, Jordan, 22110

Site: 43015

Innsbruck, Austria, 6020

Site: 48003

Warsaw, Poland, 02-929

Site: 44005

Sheffield, United Kingdom, S10 2JF

Site: 31010

Amsterdam, Netherlands

Site: 44024

West Yorkshire, United Kingdom, BD9 6RJ

Site: 45004

Hvidovre, Denmark, 2650

Site: 38004

Dnepropetrovsk, Ukraine, 49005

Site: 49007

Mainz, Germany, 55131

Site: 48001

Lublin, Poland, 20-632

Site: 32008

Deurne, Belgium, 2100

Site: 44009

Plymouth, United Kingdom, PL6 8DH

Site: 30003

Maroussi, Greece, 151 26

Site: 45001

Aarhus N, Denmark, 8200

Site: 77702

Astana, Kazakhstan, 10000

Site: 32006

Brussels, Belgium, 1070

Site: 49008

Hettstedt, Germany, 06333

Site: 45002

Aalborg, Denmark, 9000

Site: 44030

Chichester, United Kingdom, PO19 4SE

Site: 42003

Brno, Czech Republic, 602 00

Site: 42102

Zilina, Slovakia, 010 01

Site: 43013

Linz, Austria, 4020

Site: 45003

Odense C, Denmark, 9000

Site: 35306

Dublin, Ireland, 8

Site: 44029

Birmingham, United Kingdom, B15 2TG

Site: 38005

Donetsk, Ukraine, 83114

Site: 36003

Budapest, Hungary, 1082

Site: 33013

Nimes, France, 30029

Site: 10011

Barrie, Canada, L4M 7G1

Site: 10007

Kingston, Canada, K7L 3J7

Site: 40006

Judetul Constanta, Romania, 900591

Site: 46001

Stockholm, Sweden, 14186

Site: 35804

Tampere, Finland, 33521

Site: 35801

Oulu, Finland, 90029

Site: 36002

Szekszard, Hungary, 7100

Site: 70005

Moscow, Russian Federation, 117815

Site: 44010

London, United Kingdom, SW17 0QT

Site: 33009

Pierre Benite, France, 69495

Site: 48005

Wroclaw, Poland, 01-432

Site: 38001

Kharkov, Ukraine, 61057

Site: 10008

Victoria, Canada, V8V 3N1

Site: 35806

Espoo, Finland, 02100

Site: 44018

Stoke on Trent, United Kingdom, ST4 6QG

Site: 34003

Madrid, Spain, 28049

Site: 49011

Augsburg, Germany, 86150

Site: 33016

Paris Cedex 13, France, 75651

Site: 30001

Athens, Greece

Site: 37504

Vitebsk, Belarus, 210037

Site: 43009

Vienna, Austria, 1090

Site: 42006

Plzen-Lochotin, Czech Republic, 30460

Site: 39010

Pavia, Italy, 27100

Site: 30005

Alexandroupoli, Greece, 68100

Site: 10004

Toronto, Canada, M4N 3M5

Site: 10009

Sherbrooke, Canada, J1H 5N4

Site: 31002

Leiden, Netherlands, 2334 CK

Site: 35102

Matosinhos, Portugal, 4454-509

Site: 20002

Cairo, Egypt, 11381

Site: 47005

Trondheim, Norway, 7006

Site: 90004

Istanbul, Turkey

Site: 70013

Saint Petersburg, Russian Federation, 194175

Site: 33006

Marseille, France, 13385

Site: 49002

Neustadt i. Sachsen, Germany, 01844

Site: 90007

Diyarbakir, Turkey, 21080

Site: 44004

London, United Kingdom, SE5 9RS

Site: 90006

Ankara, Turkey, 6100

Site: 31003

Winterswijk, Netherlands, 7101 BN

Site: 70002

Moscow, Russian Federation, 119435

Site: 33004

Orleans Cedex 2, France, 45067

Site: 34012

Valencia, Spain, 46026

Site: 99503

Tbilisi, Georgia, 159

Site: 44020

Southampton, United Kingdom, SO16 5YA

Site: 35903

Sofia, Bulgaria, 1606

Site: 30007

Athens, Greece, 166 73

Site: 35904

Varna, Bulgaria, 9000

Site: 44006

Kent, United Kingdom, ME7 5NY

Site: 33015

Valence, France, 26953

Site: 43011

Vienna, Austria, 1020

Site: 90005

Ankara, Turkey, 06500

Site: 44025

Cambridge, United Kingdom, CB2 2QQ

Site: 32005

Liege, Belgium

Site: 40015

Judetul Cluj, Romania, 400046

Site: 35906

Sofia, Bulgaria, 1431

Site: 70003

Moscow, Russian Federation, 125206

Site: 44014

Bristol, United Kingdom, BS10 5NB

Site: 42007

Prague 4, Czech Republic, 14000

Site: 48006

Krakow, Poland, 31-315

Site: 38007

Chernivtsi, Ukraine, 58000

Site: 49004

Hamburg, Germany, 22081

Site: 33017

Tours, France, 37044

Site: 77704

Almaty, Kazakhstan, 050040

Site: 31007

Nijmegen, Netherlands, 6525 GA

Site: 33008

Nantes, France, 44093

Site: 46002

Stockholm, Sweden, 114 46

Site: 35802

Jyvaskyla, Finland, 40620

Site: 43006

Baden, Austria, 2500

Site: 30004

Patras, Greece, 26500

Site: 35907

Pleven, Bulgaria, 5800

Site: 96101

Beirut, Lebanon

Site: 49012

Sangerhausen, Germany, 06526

Site: 46005

Karlshamn, Sweden, 37435

Site: 35106

Alcabideche, Portugal, 2755-009

Site: 35803

Kuopio, Finland, 70211

Site: 47004

Sorvik, Norway, 9419

Site: 90008

Izmir, Turkey, 35340

Site: 33018

Versailles, France, 78000

Site: 34005

Madrid, Spain, 28046

Site: 37403

Yerevan, Armenia, 0052

Site: 10005

Brantford, Canada, N3R 4N3

Site: 37406

Yerevan, Armenia, 0001

Site: 40004

Judetul Mures, Romania, 540136

Site: 44013

Newcastle upon Tyne, United Kingdom, NE7 7DN

Site: 70010

Saint Petersburg, Russian Federation, 198103

Site: 42005

Prague 1, Czech Republic, 110 00

Site: 42004

Bohumin, Czech Republic, 73581

Site: 35304

Cork, Ireland

Site: 90010

Sivas, Turkey, 58140

Site: 70007

Moscow, Russian Federation, 101000

Site: 10010

Abbotsford, Canada, V2S 3N5

Site: 43016

Vienna, Austria, 1090

Site: 41003

Zurich, Switzerland, 8001

Site: 46006

Uppsala, Sweden, 753 35

Site: 38006

Zaporozhye, Ukraine, 69600

Site: 46004

Halmstad, Sweden, 302 46

Site: 70012

Saint Petersburg, Russian Federation, 196084

Site: 33010

Angers, France, 49033

Site: 37003

Vilnius, Lithuania, LT-01118

Site: 35104

Lisbon, Portugal, 1649-035

Site: 35905

Plovdiv, Bulgaria, 4003

Site: 40009

Bucharest, Romania, 011943

Site: 44011

Glasgow, United Kingdom, G11 6NT

Site: 35103

Porto, Portugal, 4100-180

Site: 39011

Rome, Italy, 00133

Site: 41002

Zurich, Switzerland, 8091

Site: 32007

Leuven, Belgium, 3000

Site: 39009

Milan, Italy, 20132

Site: 44012

Leeds, United Kingdom, LS 9TF

Site: 43004

Vienna, Austria, 1020

Site: 37503

Minsk, Belarus, 220114

Site: 40001

Bucharest, Romania, 22328

Site: 39001

Avellino, Italy, 83100

Site: 40010

Arad, Romania, 310175

Site: 43012

Vienna, Austria, 4020

Site: 32001

Edegem, Belgium, 2650

Site: 43008

Korneuburg, Austria, 2100

Site: 44007

Reading, United Kingdom, RG1 5AN

Site: 33011

Dijon, France, 21000

Site: 42103

Piestany, Slovakia, 92102

Site: 33003

Rouen, France, 76031

Site: 43010

Vienna, Austria

Site: 49006

Bad Ems, Germany, 56130

Site: 38002

Kiev, Ukraine, 2000

Site: 36001

Salgotarjan, Hungary, 3100

Site: 35301

Dublin, Ireland, 9

Site: 42002

Jihlava, Czech Republic, 586 33

Site: 42106

Martin, Slovakia, 036 59

Site: 40011

Craiova, Romania, 200349

Site: 32004

Gent, Belgium, 9000

Site: 39006

Perugia, Italy, 06156

Site: 90009

Manisa, Turkey, 45010

Site: 44002

West Yorkshire, United Kingdom, WF8 1PL

Site: 99502

Tbilisi, Georgia, 159

Site: 31006

Zwolle, Netherlands, 8025 AB

Site: 35302

Dublin, Ireland, 8

Site: 96201

Al Jabayha, Jordan

Site: 34011

Mendaro, Spain, 20850

Site: 44026

Taunton, United Kingdom, TA1 5DA

Site: 33001

Paris Cedex 20, France, 75970

Site: 36005

Csongrad, Hungary, H-6640

Site: 77705

Almaty, Kazakhstan, 050060

Site: 43003

Wels, Austria, 4600

Site: 32002

Antwerp, Belgium, 2030

Site: 10002

Montreal, Canada, H4N 3C5

Site: 38602

Maribor, Slovenia, 2000

Site: 70008

Moscow, Russian Federation, 115516

Site: 35105

Lisbon, Portugal, 1050-199

Site: 90011

Denizli, Turkey, 20070

Site: 33012

Paris, France, 75018

Site: 47003

Arendal, Norway, 4809

Site: 44003

Devon, United Kingdom, TQ2 7AA

Site: 40005

Bucharest, Romania, 50659

Site: 96202

Amman, Jordan

Site: 42001

Hradec Kralove, Czech Republic, 500 05

Site: 37505

Vitebsk, Belarus, 210604

Site: 42101

Poprad, Slovakia, 05801

Site: 31001

Tilburg, Netherlands, 5022 GC

Site: 31008

Utrecht, Netherlands, 3584 CX

Site: 40003

Bucharest, Romania, 42122

Site: 49009

Halle Saale, Germany, 06132

Site: 35902

Burgas, Bulgaria, 8000

Site: 37405

Yerevan, Armenia, 0056

Site: 44001

Edgbaston, United Kingdom, B15 2TH

Site: 90001

Izmir, Turkey, 35100

Site: 33014

Suresnes Cedex, France, 92151

Site: 34004

Madrid, Spain, 28031

Site: 10003

Brampton, Canada, L6T 4S5

Site: 34007

Vigo, Spain

Site: 42008

Prague, Czech Republic, 128 51

Site: 90002

Kocaeli, Turkey, 41380

Site: 37002

Vilnius, Lithuania, 10207

Site: 43007

Mistelbach, Austria, 2130

Site: 42104

Galanta, Slovakia, 924 22

Site: 99501

Tbilisi, Georgia, 144

Site: 40007

Iasi, Romania, 700503

Site: 37404

Yerevan, Armenia, 0014

Site: 42105

Trencin, Slovakia, 911 01

Site: 70004

St. Petersburg, Russian Federation, 197089

Site: 33002

Marseille, France, 13285

Site: 47002

Hamar, Norway, 2317

Site: 35901

Lovech, Bulgaria, 5500

Site: 49005

Berlin, Germany, 14052

Site: 77703

Astana, Kazakhstan, 010000

Site: 46003

Norrtalje, Sweden, 761 29

Site: 47001

Tonsberg, Norway, 3103

Site: 42009

Novy Jicin, Czech Republic, 741 01

Site: 31009

Amsterdam, Netherlands, 1081AS

Site: 70006

Moscow, Russian Federation, 117815

Site: 38003

Lviv, Ukraine, 79044

Site: 37401

Yerevan, Armenia, 0078

Site: 48007

Kolbuszowa Dolna, Poland, 36-100

Site: 43001

Innsbruck, Austria, 6020

Site: 34006

Gijon, Spain, 33394

Site: 39008

Milan, Italy, 20153

Site: 44023

Harrow, United Kingdom, HA 3UJ

Site: 35909

Haskovo, Bulgaria, 6300

Site: 44008

Liverpool, United Kingdom, L8 7SS

Site: 44027

Aberdeen, United Kingdom, AB25 2ZN

Site: 43002

Vienna, Austria, 1220

Site: 37102

Riga, Latvia, 1038

Site: 35305

Waterford, Ireland

Site: 77706

Almaty, Kazakhstan, 50091

Site: 39004

Terracina, Italy, 04100

Site: 37103

Liepaja, Latvia, LV-3401

Site: 34009

Bilbao, Spain, 48013

Site: 30009

Athens, Greece, 115 28

Site: 46007

Gothenburg, Sweden, 413 45

Site: 39007

Treviglio, Italy, 24047

Site: 36004

Budapest, Hungary, 1237

Site: 37501

Minsk, Belarus, 223041

Site: 35101

Setubal, Portugal, 2910-446

Site: 36006

Nyiregyhaza, Hungary, H-4400

Site: 90003

Ankara, Turkey, 6100

Site: 30010

Thessaloniki, Greece, 546 42

Site: 34010

San Sebastian, Spain, 20014

Site: 96102

Jbeil, Lebanon

Site: 48004

Piaseczno, Poland, 05-500

Site: 38601

Maribor, Slovenia, 2000

Site: 31004

Enschede, Netherlands, 7511 JX

Site: 20001

Cairo, Egypt, 11651

Site: 39002

Florence, Italy, 50139

Site: 44022

Northwood, United Kingdom, HA6 2RN

Site: 37402

Yerevan, Armenia, 0078

Site: 43005

Oberwart, Austria, 7400

Site: 40012

Bucharest, Romania, 021336

Site: 39003

Cinisello Balsamo, Italy, 20092

Site: 44016

Oxford, United Kingdom, OX3 9DU

Site: 33005

Paris Cedex 20, France, 75970

Site: 34014

Sevilla, Spain, 41014

Site: 30008

Larisa, Greece, 41334

Site: 34013

Murcia, Spain, 30008

Site: 70011

Moscow, Russian Federation, 117997

Site: 49001

Hagenow, Germany, 19230

Site: 37502

Minsk, Belarus, 220119

Site: 10006

Ottawa, Canada, K1Y 4E9

Site: 35303

Tralee, Ireland

Site: 37101

Riga, Latvia, LV-1002

Site: 40013

Bucharest, Romania, 021392

Site: 20003

Cairo, Egypt, 11451