A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,174

Participants

Timeline

Start Date

July 10, 2013

Primary Completion Date

November 24, 2014

Study Completion Date

November 25, 2014

Conditions
Urinary Bladder DiseasesUrinary Bladder OveractiveUrologic Diseases
Interventions
DRUG

mirabegron 25 mg

Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 50 mg

Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 5 mg

Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 10 mg

Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 25 mg matching placebo

Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

mirabegron 50 mg matching placebo

Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 5 mg matching placebo

Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

DRUG

solifenacin 10 mg matching placebo

Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.

Trial Locations (219)

11215

Brooklyn Urology Research Group, Brooklyn

11530

Advanced Urology Centers of New York, Garden City

12401

Premier Medical Group of the Hudson Valley PC, Kingston

12601

Premier Medical Group of the Hudson Valley PC, Poughkeepsie

19046

The Clinical Trial Center, Jenkintown

20782

MedStar Health Research Institute, Hyattsville

22304

Alexandria Clinical Research, Alexandria

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

27403

Alliance Urology Specialists, Greensboro

27518

PMG Research of Raleigh, dba PMG Research of Cary, Cary

27612

Wake Research Associates LLC, Raleigh

30024

Herman Clinical Research, Suwanee

31406

Meridian Clinical Research, LLC, Savannah

33016

Meridien Research, Brooksville

Best Quality Research Inc., Hialeah

Palmetto Professional Research, Hialeah

33407

Private Practice, West Palm Beach

33606

Meridien Research, Tampa

33613

Stedman Clinical Trials, Tampa

33756

Innovative Research of West FL, Clearwater

34741

Urology Center of Central Florida, Kissimmee

45212

The Urology Group, Cincinnati

45439

Providence Health Partners, Dayton

47130

First Urology, PSC, Jeffersonville

47630

Deaconess Gateway Health Center, Newburgh

49009

Beyer Research, Kalamazoo

57702

Health Concepts, Rapid City

68114

Quality Clinical Research, Omaha

83814

North Idaho Urology, Coeur d'Alene

84124

Jean Brown Research, Salt Lake City

85704

Genova Clinical Research, Tucson

87102

Albuquerque Clinical Trials, Inc., Albuquerque

90017

The American Institute of Research, Los Angeles

90620

Associated Pharmaceutical Research Center, Inc., Buena Park

91607

Bayview Research Group, Valley Village

02472

Bay State Clinical Trials, Inc., Watertown

Unknown

Site: 37402, Yerevan

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Site: 61001, Kogarah, Sydney

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Site: 35104, Lisbon

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Site: 35102, Matosinhos Municipality

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Site: 42113, Michalovce

Site: 42111, Nové Zámky

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Site: 42109, Žilina

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Site: 34012, Barcelona

Site: 34016, Bilbao

Site: 34013, Donostia / San Sebastian

Site: 34001, Getafe (Madrid)

Site: 34004, Madrid

Site: 34015, Madrid

Site: 34023, Mendaro

Site: 34021, Miranda de Ebro

Site: 34018, San Sebastián de los Reyes

Site: 34007, Seville

Site: 34020, Seville

Site: 34014, Vigo

Site: 46004, Halmstad

Site: 46013, Lund

Site: 46014, Norrtälje

Site: 46001, Stockholm

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Site: 46015, Umeå

Site: 41008, Baden

Site: 41001, Frauenfeld

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Site: 90002, Izmir

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Site: 90004, Manisa

Site: 90006, Sivas

Site: 44007, Bristol

Site: 44012, Cambridge

Site: 44015, Cheltenham

Site: 44019, Coventry

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Site: 44016, Kings Lynn

Site: 44017, London

Site: 44018, Northampton

Site: 44010, Nottingham

Site: 44008, Plymouth

Site: 44013, Taunton

Site: 44011, West Yorkshire

All Listed Sponsors
lead

Astellas Pharma Europe Ltd.

INDUSTRY

NCT01908829 - A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) | Biotech Hunter | Biotech Hunter