A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

PHASE4CompletedINTERVENTIONAL
Enrollment

715

Participants

Timeline

Start Date

June 13, 2016

Primary Completion Date

August 14, 2018

Study Completion Date

September 11, 2018

Conditions
Benign Prostatic HyperplasiaOveractive Bladder
Interventions
DRUG

Mirabegron

Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks.

DRUG

Placebo

Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks.

DRUG

Tamsulosin Hydrochloride

Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.

Trial Locations (79)

11530

Site US01015, Garden City

11803

Site US01019, Plainview

19230

Site DE49001, Hagenow

21287

Site US01041, Baltimore

23606

Site US01063, Newport News

24047

Site IT39001, Treviglio

25711

Site US01069, Cary

27003

Site ES34009, Lugo

28031

Site ES34001, Madrid

28650

Site US01079, Maiden

33060

Site US01026, Pompano Beach

33449

Site US01027, Wellington

33710

Site US01025, St. Petersburg

35209

Site US01009, Homewood

35749

Site US01005, Huntsville

36211

Site ES34004, Vigo

37043

Site US01042, Clarksville

37620

Site US01072, Bristol

37909

Site US01056, Knoxville

37912

Site US01075, Knoxville

37938

Site US01078, Knoxville

41014

Site ES34002, Seville

46014

Site ES34006, Valencia

47051

Site DE49002, Duisburg

50139

Site IT39004, Florence

50266

Site US01034, West Des Moines

56124

Site IT39006, Pisa

59102

Site US01067, Billings

64116

Site US01060, Kansas City

66013

Site IT39010, Chieti

66054

Site IT39008, Vasto

68024

Site FR33004, Colmar

68114

Site US01061, Omaha

69495

Site FR33002, Pierre-Bénite

71106

Site US01094, Shreveport

78501

Site CZ42001, Sternberk

80113

Site US01097, Englewood

83100

Site IT39002, Avellino

87109

Site US01031, Albuquerque

88100

Site IT39003, Catanzaro

90035

Site US01081, Los Angeles

90712

Site US01070, Hawaiian Gardens

91607

Site US01064, Valley Village

92120

Site US01068, San Diego

92562

Site US01021, Murrieta

99503

Site US01012, Anchorage

02131

Site US01016, Boston

02472

Site US01003, Watertown

08837

Site US01029, Edison

T2V 1P9

Site CA15008, Calgary

L4M 7G1

Site CA15003, Barrie

L6T 4S5

Site CA15001, Brampton

M4N 3M5

Site CA15005, Toronto

G1N 4V3

Site CA15011, Québec

J1H 5N4

Site CA15002, Sherbrooke

J1L 0H8

Site CA15009, Sherbrooke

G6P 6P6

Site CA15014, Victoriaville

256 01

Site CZ42004, Benešov

339 01

Site CZ42006, Domažlice

101 00

Site CZ42005, Prague

140 00

Site CZ42003, Prague

06295

Site DE49003, Eisleben Lutherstadt

06132

Site DE49006, Halle

D-22303

Site DE49004, Hamburg

06333

Site DE49005, Hettstedt

06526

Site DE49007, Sangerhausen

04100

Site IT39005, Latina

40-611

Site PL48006, Katowice

05-500

Site PL48001, Piaseczno

02-797

Site PL48004, Warsaw

53-114

Site PL48005, Wroclaw

53-329

Site PL48007, Wroclaw

08003

Site ES34007, Barcelona

09200

Site ES34003, Miranda de Ebro

BS10 5NB

Site GB44005, Bristol

BS48 3HA

Site GB44011, Bristol

NE7 7DN

Site GB44004, Newcastle upon Tyne

RG1 5AN

Site GB44002, Reading

YO31 8HE

Site GB44006, York

All Listed Sponsors
lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02757768 - A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) | Biotech Hunter | Biotech Hunter