Study Details

A study to evaluate the efficacy, safety and tolerability of Mirabegron and Solifenacin Succinate alone and in combination for the treatment 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).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01340027

Astellas Study ID

The unique identification code given by the study sponsor.

178-CL-100

EudraCT ID

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

2010-020601-32

Condition

Bladder Disease, Other, Overactive Bladder Disease

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

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

Mar 2011 - Jun 2012

Masking

Triple (Participant, Care Provider, Investigator)

Enrollment number

1307

A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of 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.

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Locations

DE49118

Reutlingen, Germany, 72764

RU70108

Moscow, Russian Federation, 105425

SK42107

Kosice, Slovakia, 04011

BY37103

Minsk, Belarus, 223010

RO40103

Bucharest, Romania, 200642

BY37101

Minsk, Belarus, 220036

DE49111

Sangerhausen, Germany, 06526

SK42109

Banska Bystrica, Slovakia, 975 01

HU36101

Gyor, Hungary, 9024

UA38106

Kiev, Ukraine, 01023

SK42105

Pieštany, Slovakia, 921 01

GB44108

Cambridge, United Kingdom, CB2 2QQ

HU36107

Tatabánya, Hungary, 2800

SE46103

Karlshamn, Sweden, 37435

FR33109

Paris, France, 75010

CZ42010

Roudnice nad Labem, Czech Republic, 413 01

NO47104

Elverum, Norway, 2408

BE32101

Leuven, Belgium, 3000

CZ42005

Bohumín, Czech Republic, 73581

DE49110

Neustadt i. Sachsen, Germany, 01844

RO40106

Brasov, Romania, 500152

PL48112

Wiecbork, Poland, 89-410

PL48111

Wroclaw, Poland, 01-432

UA38101

Odessa, Ukraine

PT35107

Lisbon, Portugal, 1649-035

FR33104

Colmar Cedex, France, 68024

GB44104

Nantwich, United Kingdom, CW5 5NX

NL31106

Maastricht, Netherlands

PT35102

Coimbra, Portugal, 3000-075

DE49108

Leipzig, Germany, 04105

FI35802

Tampere, Finland, 33521

ES34102

Madrid, Spain, 28905

RU70103

Saint Petersburg, Russian Federation, 194178

UA38111

Donetsk, Ukraine, 83114

FR33106

Toulouse, France, 31059

ES34101

Madrid, Spain, 28041

GB44106

Garston, United Kingdom, WD25 0EA

ES34108

Madrid, Spain, 28942

DK45101

Aarhus N, Denmark, 8200

SK42112

Bratislava, Slovakia, 832 63

RO40107

Sibiu, Romania, 550245

UA38107

Lviv, Ukraine, 79044

DE49101

Rostock, Germany, 18107

FR33103

Orleans, France, 45067

CZ42001

Prague, Czech Republic, 128 51

ES34105

Pamplona, Spain, 31008

RO40108

Bucharest, Romania, 22328

RU70109

St. Petersburg, Russian Federation, 198103

PL48107

Krakow, Poland, 31-530

ES34104

San Juan de Alicante, Spain, 03550

ES34107

Sevilla, Spain, 41014

IT39105

Florence, Italy, 50139

HU36105

Budapest, Hungary, 1076

RU70106

St. Petersburg, Russian Federation, 197089

BE32104

Edegem, Belgium, 2650

RU70102

Saint Petersburg, Russian Federation, 191015

FR33112

Paris cedex 20, France, 75970

GB44107

Plymouth, United Kingdom, PL6 8DH

DE49102

Lauchhammer, Germany, 01979

BY37104

Vitebsk, Belarus, 210037

DK45104

Holstebro, Denmark, 7500

RO40104

Bucharest, Romania, 050659

GB44110

Northwood, United Kingdom, HA6 2RN

PL48108

Lublin, Poland, 20-954

IT39101

Catanzaro, Italy, 88100

PL48103

Lodz, Poland, 90-602

HU36108

Csongrád, Hungary, 6640

PT35109

Lisbon, Portugal, 1349-019

SK42113

Malacky, Slovakia, 90101

FR33110

Tours, France, 37044

RU70110

Moscow, Russian Federation, 115682

RU70113

Ufa, Russian Federation, 450096

SK42104

Nitra, Slovakia, 949 01

FR33108

Dijon, France, 21079

IT39103

Avellino, Italy, 83100

NO47102

Hamar, Norway, 2317

FI35803

Helsinki, Finland, 00029

SK42103

Zilina, Slovakia

CZ42006

Plzen, Czech Republic, 301 24

BE32103

Gent, Belgium, 9000

PL48105

Warsaw, Poland, 02-929

RU70101

Saint Petersburg, Russian Federation, 197136

PL48104

Pulawy, Poland, 24-100

NL31104

Amsterdam, Netherlands, 1100 AD

FR33111

Paris Cedex 13, France, 75651

PL48101

Warsaw, Poland, 02-507

SK42108

Trencin, Slovakia, 911 01

RO40109

Lasi, Romania, 700503

UA38102

Donetsk, Ukraine, 83003

RO40105

Craiova, Romania, 20116

CZ42009

Prague, Czech Republic, 15006

RU70107

Saint Petersburg, Russian Federation, 198013

DE49104

Wismar, Germany, 23970

RO40101

Craiova, Romania, 20116

CZ42002

Uherske Hradiste, Czech Republic, 68608

ES34109

Madrid, Spain, 28046

PT35106

Tomar, Portugal, 2304-909

UA38109

Kiev, Ukraine, 04053

HU36103

Szekszárd, Hungary, 7100

SK42106

Piestany, Slovakia, 921 01

GB44111

Glasgow, United Kingdom, G20 0XA

PT35105

Coimbra, Portugal, 3041-801

RU70112

Kazan, Russian Federation, 420012

SE46101

Gothenburg, Sweden, 41263

HU36104

Sopron, Hungary, 9400

BE32102

Brussels, Belgium, 1090

PL48106

Piaseczno, Poland, 05-500

CZ42012

Sternberk, Czech Republic, 78501

UA38103

Zaporizhzhya, Ukraine, 69600

DE49105

Hettstedt, Germany, 06333

RO40102

Bucharest, Romania, 042122

DE49103

Göttingen, Germany, 37075

CZ42003

Hradec Kralove, Czech Republic, 500 02

GB44105

Sandbach, United Kingdom, CW11 1EQ

NL31101

Winterswijk, Netherlands, 7101 BN

GB44101

Reading, United Kingdom, RG1 5AN

NL31102

Sneek, Netherlands, 8601 ZK

UA38110

Kharkov, Ukraine, 61097

HU36110

Miskolc, Hungary, 3526

PT35101

Porto, Portugal, 4200-319

DK45102

Herlev, Denmark, 2730

PL48109

Warsaw, Poland, 00-815

DE49109

Bad Ems, Germany, 56130

PT35110

Porto, Portugal, 4099-001

SE46105

Tanumshede, Sweden, 45781

CZ42007

Prague 4, Czech Republic, 14000

RU70104

Moscow, Russian Federation, 111123

SK42101

Trenčín, Slovakia, 91101

PT35104

Lisbon, Portugal, 1050-199

IT39104

Ancona, Italy, 60126

SK42102

Presov, Slovakia, 08001

NO47103

Drammen, Norway, 3016

FI35804

Kouvola, Finland, 45200

SE46102

Stockholm, Sweden, 14186

ES34103

Madrid, Spain, 28031

ES34106

Barcelona, Spain, 8036

DE49117

Hagenow, Germany, 19230

HU36106

Körmend, Hungary, 9900

UA38104

Dnepropetrovsk, Ukraine, 49005

BY37102

Minsk, Belarus, 220119

IT39102

Treviglio (BG), Italy, 24047

SE46104

Malmo, Sweden, 21152

GB44103

Bristol, United Kingdom, BS10 5NB

CZ42011

Ostrava, Czech Republic, 700 30

FI35801

Oulu, Finland, 90220