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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,829

Participants

Timeline

Start Date

March 17, 2014

Primary Completion Date

September 8, 2016

Study Completion Date

September 8, 2016

Conditions
Urinary Bladder OveractiveOveractive BladderUrgency IncontinenceUrinary Bladder Diseases\Urologic Diseases
Interventions
DRUG

Solifenacin succinate

Participants received solifenacin 5 mg orally once a day at the same time each day.

DRUG

Mirabegron

Participants received mirabegron 50 mg orally once a day at the same time each day.

DRUG

Placebo to match solifenacin

Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

DRUG

Placebo to match mirabegron

Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Trial Locations (251)

1431

Site BG35905, Sofia

1606

Site BG35903, Sofia

1709

Site ZA27002, Roodepoort

2031

Site AU61007, Randwick

Site AU61021, Randwick

2292

Site AU61005, Broadmeadow

2317

Site NO47006, Hamar

2522

Site AU61011, Wollongong

3011

Site AU61025, Footscray

3052

Site AU61002, Parkville

3140

Site NZ64003, Tauranga

3420

Site NO47008, Lierskogen

3800

Site BE32012, Sint-Truiden

4001

Site ZA27006, Durban

4003

Site BG35908, Plovdiv

4075

Site AU61019, Sherwood

4152

Site AU61022, Brisbane

4560

Site AU61010, Nambour

5041

Site AU61015, Daw Park

6000

Site HU36007, Kecskemét

6003

Site NO47007, Ålesund

6009

Site AU61004, Perth

6600

Site HU36001, Szentes

6640

Site HU36003, Csongrád

7000

Site BG35902, Rousse

7010

Site NZ64002, Nelson

7621

Site HU36005, Pécs

7646

Site ZA27007, Paarl

8013

Site NZ64001, Christchurch

8200

Site DK45013, Aarhus

Site HU36012, Veszprém

8800

Site BE32014, Roeselare

9000

Site BE32004, Ghent

Site SI38604, Murska Sobota

9400

Site HU36013, Sopron

10065

Site US10168, New York

10207

Site LT37010, Vilnius

10400

Site TH66008, Bangkok

11530

Site US10026, Garden City

12401

Site US10040, Kingston

12550

Site US10126, Newburgh

12601

Site US10028, Poughkeepsie

12808

Site CZ42008, Prague

14034

Site UA38002, Cherenigiv

15213

Site US10167, Pittsburgh

15236

Site US10250, Pittsburgh

15243

Site US10248, Pittsburgh

15401

Site US10063, Uniontown

18107

Site DE49026, Rostock

19004

Site US10008, Bala-Cynwyd

19114

Site US10017, Philadelphia

19611

Site US10012, West Reading

20100

Site IT39020, Milan

21076

Site US10558, Hanover

23462

Site US10083, Virginia Beach

27103

Site US10062, Winston-Salem

27609

Site US10129, Raleigh

27777

Site DE49010, Ganderkesee

28025

Site US10076, Concord

28031

Site ES34004, Madrid

28044

Site ES34015, Madrid

28046

Site ES34009, Madrid

29425

Site US10166, Charleston

29464

Site US10079, Mt. Pleasant

29485

Site US10101, Summerville

29681

Site US10023, Simpsonville

30005

Site US10037, Alpharetta

30076

Site US10127, Roswell

30328

Site US10120, Sandy Springs

32600

Site CZ42005, Pilsen

32803

Site US10124, Orlando

32806

Site US10134, Orlando

33012

Site US10097, Hialeah

33016

Site US10148, Hialeah

Site US10153, Hialeah

33027

Site US10009, Pembroke Pines

33317

Site US10554, Plantation

33458

Site US10091, Jupiter

34208

Site US10060, Bradenton

34652

Site US10150, New Port Richey

36608

Site US10049, Mobile

Site US10112, Mobile

37660

Site US10006, Kingsport

40001

Site CZ42006, Ústí nad Labem

40002

Site TH66009, Khon Kaen

44122

Site US10050, Cleveland

44281

Site US10067, Wadsworth

45200

Site FI35801, Kouvola

46026

Site ES34002, Valencia

47051

Site DE49002, Duisburg

47144

Site LT37008, Kaunas

47179

Site DE49032, Duisburg

47500

Site MY60002, Petaling Jaya

49005

Site UA38013, Dnipro

50005

Site CZ42001, Hradec Králové

50009

Site LT37004, Kaunas

50659

Site RO40001, Bucharest

Site RO40005, Bucharest

51427

Site DE49031, Bergisch Gladbach

56130

Site DE49008, Bad Ems

58002

Site UA38015, Chernivtsi

59102

Site US10110, Billings

59801

Site US10154, Missoula

60126

Site IT39022, Ancona

67205

Site US10078, Wichita

68510

Site US10553, Lincoln

69600

Site UA38008, Zaporizhzhya

70601

Site US10088, Lake Charles

71106

Site US10025, Shreveport

73112

Site US10109, Oklahoma City

76054

Site US10090, Hurst

77058

Site US10085, Houston

77094

Site US10219, Houston

77099

Site US10093, Houston

78229

Site US10105, San Antonio

Site US10111, San Antonio

78414

Site US10065, Corpus Christi

78501

Site CZ42013, Sternberk

80010

Site EE37201, Pärnu

80033

Site US10053, Wheat Ridge

81377

Site DE49034, Munich

82101

Site SK42105, Bratislava

83100

Site IT39007, Avellino

85051

Site US10021, Phoenix

85224

Site US10104, Chandler

87102

Site US10011, Albuquerque

87109

Site US10015, Albuquerque

90017

Site US10132, Los Angeles

90036

Site US10133, Los Angeles

90716

Site US10082, Hawaiian Gardens

90723

Site US10149, Paramount

91101

Site SK42102, Trenčín

Site SK42106, Trenčín

91356

Site US10106, Tarzana

91607

Site US10595, Valley Village

92120

Site US10003, San Diego

92801

Site US10122, Anaheim

97504

Site US10541, Medford

98043

Site US10004, Mountlake Terrace

98105

Site US10155, Seattle

98166

Site US10013, Burien

99362

Site US10135, Walla Walla

169608

Site SG65002, Singapore

194354

Site RU70019, Saint Petersburg

197089

Site RU70002, Saint Petersburg

198103

Site RU70022, Saint Petersburg

199178

Site RU70014, Saint Petersburg

229899

Site SG65003, Singapore

300736

Site RO40002, Timișoara

400046

Site RO40014, Cluj-Napoca

405760

Site KR82023, Incheon

420097

Site RU70015, Kazan'

440026

Site RU70023, Penza

450096

Site RU70018, Ufa

550245

Site RO40010, Sibiu

02131

Site US10282, Boston

02472

Site US10114, Watertown

07631

Site US10002, Englewood

08648

Site US10047, Lawrenceville

T5G 0B7

Site CA15035, Edmonton

V5Z 4E1

Site CA15033, Vancouver

E2L 3J8

Site CA15008, Saint John

L4M 7G1

Site CA15001, Barrie

L6T 4S5

Site CA15006, Brampton

N3S 6T6

Site CA15003, Brantford

N2N 2B9

Site CA15007, Kitchener

M4N 3M5

Site CA15013, Toronto

M4S 1Y2

Site CA15004, Toronto

J2B 7T1

Site CA15026, Drummondville

G6W 5M6

Site CA15039, Lévis

H4N 3C5

Site CA15020, Montreal

G1S 2L6

Site CA15025, Québec

J1H 1Z1

Site CA15027, Sherbrooke

H2R 1V6

Site CA15040, Montreal

602 00

Site CZ42015, Brno

500 02

Site CZ42003, Hradec Králové

772 00

Site CZ42010, Olomouc

700 30

Site CZ42014, Ostrava

140 00

Site CZ42007, Prague

686 08

Site CZ42009, Uherské Hradiště

04105

Site DE49013, Leipzig

06295

Site DE49003, Eisleben Lutherstadt

06132

Site DE49011, Halle

01844

Site DE49001, Neustadt in Sachsen

06526

Site DE49014, Sangerhausen

04100

Site IT39001, Latina

LV-3401

Site LV37102, Liepāja

LV-2114

Site LV37103, Olaine

LV-1002

Site LV37105, Riga

LT49449

Site LT37011, Kaunas

LT-92288

Site LT37012, Klaipėda

LT-01118

Site LT37003, Vilnius

LT-08661

Site LT37007, Vilnius

LT-09108

Site LT37009, Vilnius

06700

Site MX52003, Mexico City

7513ER

Site NL31006, Enschede

1105 AZ

Site NL31002, Amsterdam

6532 SZ

Site NL31005, Nijmegen

8601 ZK

Site NL31010, Sneek

0112

Site NZ64006, Whangarei

15-351

Site PL48018, Bialystok

41-500

Site PL48013, Chorzów

81-384

Site PL48014, Gdynia

90-302

Site PL48004, Lodz

20-632

Site PL48010, Lublin

41-400

Site PL48011, Mysłowice

45-086

Site PL48016, Opole

05-500

Site PL48005, Piaseczno

00-909

Site PL48012, Warsaw

02-507

Site PL48003, Warsaw

02-929

Site PL48001, Warsaw

50-088

Site PL48019, Wroclaw

042122

Site RO40004, Bucharest

04001

Site SK42107, Košice

04013

Site SK42101, Košice

949 01

Site SK42103, Nitra

05801

Site SK42108, Poprad

080 01

Site SK42104, Prešov

0157

Site ZA27001, Centurion

0184

Site ZA27013, Meyerspark

443-721

Site KR82004, Suwon

420-767

Site KR82014, Bucheon-si

143-729

Site KR82012, Seoul

561-712

Site KR82010, Jeonju

602-715

Site KR82006, Busan

602-739

Site KR82016, Busan

705-717

Site KR82005, Daegu

705-718

Site KR82029, Daegu

301-721

Site KR82019, Daejeon

05505

Site KR82003, Seoul

100-380

Site KR82021, Seoul

110-744

Site KR82020, Seoul

120-752

Site KR82030, Seoul

134-701

Site KR82013, Seoul

134-872

Site KR82017, Seoul

135-710

Site KR82002, Seoul

135-720

Site KR82008, Seoul

136-075

Site KR82015, Seoul

137-701

Site KR82001, Seoul

506 30

Site SE46007, Borås

211 52

Site SE46005, Malmo

111 57

Site SE46016, Stockholm

141 86

Site SE46012, Stockholm

182 88

Site SE46003, Stockholm

753 19

Site SE46009, Uppsala

02232

Site UA38007, Kiev

02660

Site UA38003, Kyiv

04053

Site UA38010, Kyiv

S10 2JF

Site GB44001, Sheffield

PL6 8DH

Site GB44006, Plymouth

WD25 7NL

Site GB44009, Watford

All Listed Sponsors
lead

Astellas Pharma Europe B.V.

INDUSTRY

NCT02045862 - 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 | Biotech Hunter | Biotech Hunter