Study Details

A multinational study comparing the long-term efficacy and safety of two medicines, solifenacin succinate and mirabegron taken together, or separately, in subjects with symptoms of overactive bladder

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). ID

The unique identification code given to each clinical study upon registration at

Astellas Study ID

The unique identification code given by the study sponsor.


EudraCT ID

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



Overactive Bladder Disease, Urge to Urinate, Bladder Disease


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


18 years - N/A


Female & Male




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.


Trial Dates

Mar 2014 - Sep 2016


Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number


A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder

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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Site KR82005

Daegu, Republic of Korea, 705-717

Site US10002

Englewood, United States, 07631

Site KR82008

Seoul, Republic of Korea, 135-720

Site UA38010

Kyiv, Ukraine, 04053

Site UA38004

Vinnytsya, Ukraine, 21010

Site US10006

Kingsport, United States, 37660

Site LV37102

Liepaja, Latvia, LV-3401

Site US10003

San Diego, United States, 92120

Site EE37201

Parnu, Estonia, 80010

Site US10060

Bradenton, United States, 34208

Site CA15035

Edmonton, Canada, T5G 0B7

Site AU61019

Sherwood, Australia, 4075

Site AU61026

Ballarat, Australia, 3350

Site KR82013

Seoul, Republic of Korea, 134-701

Site HU36001

Szentes, Hungary, 6600

Site KR82012

Seoul, Republic of Korea, 143-729

Site LT37004

Kaunas, Lithuania, 50009

Site CZ42013

Sternberk, Czech Republic, 78501

Site PL48010

Lublin, Poland, 20-632

Site NO47007

Alesund, Norway, 6003

Site GB44001

Sheffield, United Kingdom, S10 2JF

Site PL48016

Opole, Poland, 45-086

Site US10558

Hanover, United States, 21076

Site US10009

Pembroke Pines, United States, 33027

Site RU70023

Penza, Russian Federation, 440026

Site IT39022

Ancona, Italy, 60126

Site CA15001

Barrie, Canada, L4M 7G1

Site TH66009

Khon Kaen, Thailand, 40002

Site CA15026

Drummondville, Canada, J2B 7T1

Site US10010

Tallahassee, United States, 32308

Site RO40005

Bucuresti, Romania, 50659

Site RO40014

Cluj-Napoca, Romania, 400046

Site SK42103

Nitra, Slovakia, 949 01

Site RU70014

St. Petersburg, Russian Federation, 199178

Site SI38604

Murska Sobota, Slovenia, 9000

Site CA15039

Levis, Canada, G6W 5M6

Site GB44006

Plymouth, United Kingdom, PL6 8DH

Site US10148

Hialeah, United States, 33016

Site US10126

Newburgh, United States, 12550

Site CZ42007

Praha 4, Czech Republic, 140 00

Site US10079

Mount Pleasant, United States, 29464

Site DE49013

Leipzig, Germany, 04105

Site PL48003

Warszawa, Poland, 02-507

Site NZ64006

Whangarei, New Zealand, 0112

Site RU70019

Saint Petersburg, Russian Federation, 194354

Site LT37009

Vilnius, Lithuania, LT-09108

Site SE46003

Stockholm, Sweden, 182 88

Site US10062

Winston-Salem, United States, 27103

Site US10109

Oklahoma City, United States, 73112

Site DE49010

Ganderkesee, Germany, 27777

Site US10021

Phoenix, United States, 85051

Site ZA27013

Meyerspark, South Africa, 0184

Site US10110

Billings, United States, 59102

Site US10134

Orlando, United States, 32806

Site KR82020

Seoul, Republic of Korea, 110-744

Site US10063

Uniontown, United States, 15401

Site AU61010

Nambour, Australia, 4560

Site US10028

Poughkeepsie, United States, 12601

Site CA15008

Saint John, Canada, E2L 3J8

Site ZA27006

Durban, South Africa, 4001

Site SE46016

Stockholm, Sweden, 111 57

Site TH66006

Hat Yai, Thailand, 90110

Site US10091

Jupiter, United States, 33458

Site US10132

Los Angeles, United States, 90017

Site KR82014

Bucheon-Si, Republic of Korea, 420-767

Site SE46012

Stockholm, Sweden, 141 86

Site DE49002

Duisburg, Germany, 47051

Site CA15004

Toronto, Canada, M4S 1Y2

Site NZ64002

Nelson, New Zealand, 7010

Site SE46005

Malmo, Sweden, 211 52

Site HU36003

Csongrad, Hungary, 6640

Site AU61007

Randwick, Australia, 2031

Site AU61005

Broadmeadow, Australia, 2292

Site NL31010

Sneek, Netherlands, 8601 ZK

Site CZ42003

Hradec Kralove, Czech Republic, 500 02

Site US10556

State College, United States, 16801

Site US10050

Cleveland, United States, 44122

Site NO47006

Hamar, Norway, 2317

Site ZA27001

Centurion, South Africa, 0157

Site CA15033

Vancouver, Canada, V5Z 4E1

Site AU61015

Daw Park, Australia, 5041

Site BE32012

Sint-Truiden, Belgium, 3800

Site US10166

Charleston, United States, 29425

Site US10112

Mobile, United States, 36608

Site US10553

Lincoln, United States, 68510

Site US10092

Draper, United States, 84020

Site HU36005

Pecs, Hungary, 7621

Site CZ42010

Olomouc, Czech Republic, 772 00

Site US10011

Albuquerque, United States, 87102

Site US10008

Bala Cynwyd, United States, 19004

Site UA38008

Zaporizhzhya, Ukraine, 69600

Site KR82030

Seoul, Republic of Korea, 120-752

Site PL48011

Myslowice, Poland, 41-400

Site RU70022

Saint Petersburg, Russian Federation, 198103

Site ES34015

Madrid, Spain, 28044

Site UA38003

Kyiv, Ukraine, 02660

Site BE32014

Roeselare, Belgium, 8800

Site UA38002

Cherenigiv, Ukraine, 14034

Site US10004

Mountlake Terrace, United States, 98043

Site BG35906

Varna, Bulgaria, 9000

Site RO40001

Bucuresti, Romania, 50659

Site GB44005

Harrow, United Kingdom, HA1 3UJ

Site US10026

Garden City, United States, 11530

Site US10049

Mobile, United States, 36608

Site US10129

Raleigh, United States, 27609

Site US10540

Pembroke Pines, United States, 33028

Site MX52003

Mexico City, Mexico, 06700

Site US10127

Roswell, United States, 30076

Site US10153

Hialeah, United States, 33016

Site US10124

Orlando, United States, 32803

Site SK42106

Trencin, Slovakia, 91101

Site KR82023

Incheon, Republic of Korea, 405760

Site US10219

Houston, United States, 77094

Site US10085

Houston, United States, 77058

Site US10248

Pittsburgh, United States, 15243

Site DE49014

Sangerhausen, Germany, 06526

Site US10122

Anaheim, United States, 92801

Site CA15025

Quebec, Canada, G1S 2L6

Site CZ42008

Praha 2, Czech Republic, 12808

Site CA15020

Montreal, Canada, H4N 3C5

Site LT37003

Vilnius, Lithuania, LT-01118

Site IT39020

Milano, Italy, 20100

Site KR82021

Seoul, Republic of Korea, 100-380

Site HU36012

Veszprem, Hungary, 8200

Site US10067

Wadsworth, United States, 44281

Site US10282

Boston, United States, 02131

Site NL31005

Nijmegen, Netherlands, 6532 SZ

Site BG35902

Ruse, Bulgaria, 7000

Site PL48018

Bialystok, Poland, 15-351

Site US10554

Plantation, United States, 33317

Site KR82031

Gwangju, Republic of Korea, 501757

Site DE49003

Lutherstadt Eisleben, Germany, 06295

Site UA38013

Dnepropetrovsk, Ukraine, 49005

Site US10023

Simpsonville, United States, 29681

Site NZ64003

Tauranga, New Zealand, 3140

Site US10595

Valley Village, United States, 91607

Site AU61025

Footscray, Australia, 3011

Site HU36013

Sopron, Hungary, 9400

Site KR82004

Suwon-si, Republic of Korea, 443-721

Site US10128

New Milford, United States, 06776

Site IT39007

Avellino, Italy, 83100

Site CA15007

Kitchener, Canada, N2N 2B9

Site US10098

Cerritos, United States, 90703

Site DE49008

Bad Ems, Germany, 56130

Site PL48012

Warsaw, Poland, 00-909

Site FI35801

Kouvola, Finland, 45200

Site HU36007

Kecskemet, Hungary, 6000

Site US10084

Austin, United States, 78745

Site US10014

Wellington, United States, 33449

Site US10082

Hawaiian Gardens, United States, 90716

Site SK42104

Prešov, Slovakia, 080 01

Site KR82010

Jeonju-si, Republic of Korea, 561-712

Site US10149

Paramount, United States, 90723

Site AU61008

Richmond, Australia, 3121

Site LT37007

Vilnius, Lithuania, LT-08661

Site US10120

Sandy Springs, United States, 30328

Site US10162

Moorestown, United States, 08057

Site BG35908

Plovdiv, Bulgaria, 4003

Site BG35905

Sofia, Bulgaria, 1431

Site ES34009

Madrid, Spain, 28046

Site KR82006

Busan, Republic of Korea, 602-715

Site SK42108

Poprad, Slovakia, 05801

Site US10168

New York, United States, 10065

Site KR82015

Seoul, Republic of Korea, 136-075

Site PL48014

GDYNIA, Poland, 81-384

Site US10135

Walla Walla, United States, 99362

Site SE46007

Boras, Sweden, 506 30

Site AU61011

Wollongong, Australia, 2522

Site SK42102

Trencin, Slovakia, 91101

Site SI38602

Novo Mesto, Slovenia, 8000

Site BG35903

Sofia, Bulgaria, 1606

Site UA38007

Kiev, Ukraine, 02232

Site CA15006

Brampton, Canada, L6T 4S5

Site CZ42005

Plzen, Czech Republic, 32600

Site LT37011

Kaunas, Lithuania, LT49449

Site DE49026

Rostock, Germany, 18107

Site IT39001

Latina, Italy, 04100

Site UA38014

Uzhorod, Ukraine, 88000

Site GB44025

London, United Kingdom, SE5 9RS

Site US10088

Lake Charles, United States, 70601

Site US10154

Missoula, United States, 59801

Site KR82002

Seoul, Republic of Korea, 135-710

Site KR82019

Daejeon, Republic of Korea, 301-721

Site CZ42006

Usti nad Labem, Czech Republic, 40001

Site SG65002

Singapore, Singapore, 169608

Site LT37008

Kaunas, Lithuania, 47144

Site US10111

San Antonio, United States, 78229

Site DE49032

Duisburg, Germany, 47179

Site MY60002

Petaling Jaya, Malaysia, 47500

Site KR82017

Seoul, Republic of Korea, 134-872

Site US10076

Concord, United States, 28025

Site US10037

Alpharetta, United States, 30005

Site US10250

Pittsburgh, United States, 15236

Site PL48019

Wrocław, Poland, 50-088

Site KR82016

Busan, Republic of Korea, 602-739

Site US10012

West Reading, United States, 19611

Site NO47008

Lierskogen, Norway, 3420

Site ES34002

Valencia, Spain, 46026

Site US10053

Wheatridge, United States, 80033

Site AU61004

Perth, Australia, 6009

Site SE46009

Uppsala, Sweden, 753 19

Site US10114

Watertown, United States, 02472

Site AU61021

Randwick, Australia, 2031

Site RU70018

Ufa, Russian Federation, 450096

Site CA15013

Toronto, Canada, M4N 3M5

Site BG35910

Veliko Tarnovo, Bulgaria, 5000

Site LV37105

Riga, Latvia, LV-1002

Site DK45013

Aarhus, Denmark, 8200

Site US10078

Wichita, United States, 67205

Site US10101

Summerville, United States, 29485

Site NL31006

Enschede, Netherlands, 7513ER

Site US10015

Albuquerque, United States, 87109

Site ZA27007

Paarl, South Africa, 7646

Site PL48004

Lodz, Poland, 90-302

Site RU70002

Saint Petersburg, Russian Federation, 197089

Site PL48005

Piaseczno, Poland, 05-500

Site CA15040

Montreal, Canada, H2R 1V6

Site US10106

Tarzana, United States, 91356

Site NZ64001

Christchurch, New Zealand, 8013

Site SK42105

Bratislava, Slovakia, 82101

Site US10105

San Antonio, United States, 78229

Site US10541

Medford, United States, 97504

Site PL48001

Warszawa, Poland, 02-929

Site CZ42015

Brno, Czech Republic, 602 00

Site CA15031

Kingston, Canada, K7L 3J7

Site US10095

Sarasota, United States, 34237

Site CZ42001

Hradec Kralove, Czech Republic, 50005

Site US10065

Corpus Christi, United States, 78414

Site US10070

Lakewood, United States, 80228

Site DE49031

Bergisch Gladbach, Germany, 51427

Site CA15003

Brantford, Canada, N3S 6T6

Site US10017

Philadelphia, United States, 19114

Site KR82001

Seoul, Republic of Korea, 137-701

Site DE49034

Munich, Germany, 81377

Site US10133

Los Angeles, United States, 90036

Site BE32004

Gent, Belgium, 9000

Site NL31002

Amsterdam, Netherlands, 1105 AZ

Site DE49011

Halle (Saale), Germany, 06132

Site UA38015

Chernivtsi, Ukraine, 58002

Site US10104

Chandler, United States, 85224

Site CZ42009

Uherske Hradiste, Czech Republic, 686 08

Site US10047

Lawrenceville, United States, 08648

Site US10040

Kingston, United States, 12401

Site US10083

Virginia Beach, United States, 23462

Site US10167

Pittsburgh, United States, 15213

Site US10150

New Port Richey, United States, 34652

Site ZA27002

Roodepoort, South Africa, 1709

Site AU61002

Parkville, Australia, 3052

Site PL48013

Chorzow, Poland, 41-500

Site AU61012

Malvern, Australia, 3144

Site KR82029

Daegu, Republic of Korea, 705-718

Site SK42107

Kosice, Slovakia, 04001

Site AU61022

Brisbane, Australia, 4152

Site GB44009

Watford, United Kingdom, WD25 7NL

Site CA15027

Sherbrooke, Canada, J1H 1Z1

Site SK42101

Kosice, Slovakia, 04013

Site US10155

Seattle, United States, 98105

Site RU70015

Kazan, Russian Federation, 420097

Site TH66008

Bangkok, Thailand, 10400

Site RO40004

Bucuresti, Romania, 042122

Site CA15037

London, Canada, N6A 4V2

Site RO40010

Sibiu, Romania, 550245

Site US10093

Houston, United States, 77099

Site US10097

Hialeah, United States, 33012

Site US10090

Hurst, United States, 76054

Site US10025

Shreveport, United States, 71106

Site CZ42014

Ostrava, Czech Republic, 700 30

Site SG65003

Singapore, Singapore, 229899

Site ES34004

Madrid, Spain, 28031

Site KR82003

Seoul, Republic of Korea, 05505

Site LT37012

Klaipeda, Lithuania, LT-92288

Site US10013

Burien, United States, 98166

Site RO40002

Timisoara, Romania, 300736

Site LT37010

Vilnius, Lithuania, 10207

Site DE49001

Neustadt i. Sachsen, Germany, 01844

Site LV37103

Olaine, Latvia, LV-2114