Study summary

The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

Additional Study Details

Phase
4
Product
N/A
Product
Mirabegron
Placebo
Tamsulosin Hydrochloride
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment number
715
Show Additional Study Details

Study documents

Scientific Results Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English
Protocol
Available Language(s): English
Statistical Analysis Plan (SAP)
Available Language(s): English

Get more information

Would you like more information about clinical trial sites that are recruiting participants for 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)? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

    Locations

    Contact Us
    Contact Us
    Completed
    Site ES34004
    Vigo, Spain, 36211
    Withdrawn
    Site US01053
    Hialeah, FL, United States, 33016
    Completed
    Site GB44005
    Bristol, United Kingdom, BS10 5NB
    Completed
    Site CA15005
    Toronto, ON, Canada, M4N 3M5
    Completed
    Site GB44011
    Bristol, United Kingdom, BS48 3HA
    Completed
    Site CZ42003
    Praha 4, Czech Republic, 140 00
    Withdrawn
    Site US01084
    Melrose Park, IL, United States, 60160
    Completed
    Site DE49004
    Hamburg, Germany, D-22303
    Completed
    Site ES34003
    Miranda de Ebro, Spain, 09200
    Completed
    Site US01067
    Billings, MT, United States, 59102
    Withdrawn
    Site US01048
    Las Vegas, NV, United States, 89106
    Withdrawn
    Site US01013
    Burien, WA, United States, 98166
    Completed
    Site US01056
    Knoxville, TN, United States, 37909
    Withdrawn
    Site US01020
    Brooklyn, NY, United States, 11215
    Completed
    Site FR33004
    Colmar Cedex, France, 68024
    Withdrawn
    Site CA15004
    Toronto, ON, Canada, M6A 3B5
    Completed
    Site CA15008
    Calgary, AB, Canada, T2V 1P9
    Completed
    Site US01075
    Knoxville, TN, United States, 37912
    Withdrawn
    Site GB44003
    Cambridge, United Kingdom, CB2 2QQ
    Completed
    Site ES34001
    Madrid, Spain, 28031
    Withdrawn
    Site US01051
    Hanover, MD, United States, 21076
    Withdrawn
    Site US01035
    Springfield, IL, United States, 62769
    Withdrawn
    Site US01066
    Albuquerque, NM, United States, 87102
    Withdrawn
    Site US01052
    Tucson, AZ, United States, 85715
    Completed
    Site PL48004
    Warszawa, Poland, 02-797
    Withdrawn
    Site US01057
    Las Vegas, NV, United States, 89144
    Completed
    Site US01063
    Newport News, VA, United States, 23606
    Withdrawn
    Site US01054
    Greenwood, IN, United States, 46143
    Completed
    Site US01019
    Plainview, NY, United States, 11803
    Withdrawn
    Site US01082
    Atlanta, GA, United States, 30312
    Withdrawn
    Site US01071
    Mount Pleasant, SC, United States, 29464
    Withdrawn
    Site US01058
    Redwood City, CA, United States, 94062
    Withdrawn
    Site US01033
    Milwaukee, WI, United States, 29425
    Completed
    Site US01078
    Knoxville, TN, United States, 37938
    Withdrawn
    Site US01036
    Los Angeles, CA, United States, 90048
    Completed
    Site CA15009
    Sherbrooke, QC, Canada, J1L 0H8
    Completed
    Site IT39006
    Pisa, Italy, 56124
    Withdrawn
    Site US01007
    Middleburg Heights, OH, United States, 44130
    Completed
    Site US01042
    Clarksville, TN, United States, 37043
    Completed
    Site CZ42004
    Benesov, Czech Republic, 256 01
    Completed
    Site DE49003
    Lutherstadt Eisleben, Germany, 06295
    Withdrawn
    Site US01095
    San Antonio, TX, United States, 78229
    Completed
    Site PL48005
    Wrocław, Poland, 53-114
    Withdrawn
    Site FR33003
    Rouen, France, 76031
    Completed
    Site IT39010
    Chieti, Italy, 66013
    Withdrawn
    Site US01022
    Augusta, GA, United States, 30912
    Withdrawn
    Site US01002
    Denver, CO, United States, 80211
    Withdrawn
    Site US01028
    Los Angeles, CA, United States, 90027
    Completed
    Site ES34002
    Sevilla, Spain, 41014
    Completed
    Site CA15003
    Barrie, ON, Canada, L4M 7G1
    Completed
    Site IT39008
    Vasto, Italy, 66054
    Completed
    Site US01064
    Valley Village, CA, United States, 91607
    Completed
    Site DE49001
    Hagenow, Germany, 19230
    Withdrawn
    Site US01045
    Sugar Land, TX, United States, 77478
    Completed
    Site ES34006
    Valencia, Spain, 46014
    Completed
    Site IT39003
    Catanzaro, Italy, 88100
    Completed
    Site US01027
    Wellington, FL, United States, 33449
    Withdrawn
    Site US01092
    Cleveland, OH, United States, 44122
    Withdrawn
    Site US01096
    West Jordan, UT, United States, 84088
    Completed
    Site IT39005
    Latina, Italy, 04100
    Completed
    Site GB44004
    Newcastle upon Tyne, United Kingdom, NE7 7DN
    Completed
    Site PL48007
    Wroclaw, Poland, 53-329
    Withdrawn
    Site US01032
    Voorhees, NJ, United States, 08053
    Completed
    Site US01012
    Anchorage, AK, United States, 99503
    Withdrawn
    Site US01014
    Poughkeepsie, NY, United States, 12601
    Completed
    Site DE49006
    Halle (Saale), Germany, 06132
    Completed
    Site CZ42005
    Prague 10, Czech Republic, 101 00
    Withdrawn
    Site US01083
    Tucson, AZ, United States, 85710
    Completed
    Site GB44002
    Reading, United Kingdom, RG1 5AN
    Withdrawn
    Site ES34005
    Orense, Spain, 32005
    Completed
    Site PL48001
    Piaseczno, Poland, 05-500
    Withdrawn
    Site US01093
    Troy, MI, United States, 48084
    Completed
    Site US01029
    Edison, NJ, United States, 08837
    Completed
    Site CA15014
    Victoriaville, QC, Canada, G6P 6P6
    Completed
    Site US01068
    San Diego, CA, United States, 92120
    Withdrawn
    Site US01088
    San Jose, CA, United States, 95124
    Completed
    Site US01070
    Hawaiian Gardens, CA, United States, 90712
    Completed
    Site CA15002
    Sherbrooke, QC, Canada, J1H 5N4
    Withdrawn
    Site CA15006
    Montreal, QC, Canada, H3T 1E2
    Completed
    Site US01041
    Baltimore, MD, United States, 21287
    Completed
    Site DE49005
    Hettstedt, Germany, 06333
    Withdrawn
    Site US01073
    Charlotte, NC, United States, 28277
    Withdrawn
    Site US01059
    Santa Maria, CA, United States, 93454
    Completed
    Site IT39001
    Treviglio, Italy, 24047
    Withdrawn
    Site US01087
    Bala Cynwyd, PA, United States, 19004
    Completed
    Site US01015
    Garden City, NY, United States, 11530
    Withdrawn
    Site CA15012
    Abbotsford, BC, Canada, V2S3N6
    Withdrawn
    Site FR33007
    Valence, France, 26953 Cedex 9
    Completed
    Site IT39002
    Avellino, Italy, 83100
    Withdrawn
    Site US01044
    Goodyear, AZ, United States, 85395
    Completed
    Site IT39004
    Florence, Italy, 50139
    Completed
    Site ES34007
    Barcelona, Spain, 08003
    Withdrawn
    Site FR33001
    Bordeaux, Gironde, France, 33076
    Completed
    Site US01034
    West Des Moines, IA, United States, 50266
    Withdrawn
    Site US01010
    Wichita, KS, United States, 67208
    Completed
    Site FR33002
    Pierre Benite Cedex, France, 69495
    Completed
    Site US01072
    Bristol, TN, United States, 37620
    Completed
    Site US01026
    Pompano Beach, FL, United States, 33060
    Completed
    Site US01021
    Murrieta, CA, United States, 92562
    Completed
    Site US01005
    Huntsville, AL, United States, 35749
    Withdrawn
    Site US01055
    New Orleans, LA, United States, 70121
    Completed
    Site US01009
    Homewood, AL, United States, 35209
    Completed
    Site DE49002
    Duisburg, Germany, 47051
    Completed
    Site DE49007
    Sangerhausen, Germany, 06526
    Completed
    Site US01069
    Cary, NC, United States, 25711
    Completed
    Site CA15011
    Quebec City, QC, Canada, G1N 4V3
    Completed
    Site US01079
    Maiden, NC, United States, 28650
    Withdrawn
    Site FR33006
    Lille, France, 59037
    Withdrawn
    Site US01017
    Greenbelt, MD, United States, 20770
    Withdrawn
    Site GB44007
    Middlesborough, United Kingdom, TS4 3BW
    Completed
    Site CZ42006
    Domazlice, Czech Republic, 339 01
    Withdrawn
    Site IT39007
    Rome, Italy, 00189
    Withdrawn
    Site US01077
    Charlotte, NC, United States, 28209
    Withdrawn
    Site US01046
    Indianapolis, IN, United States, 46202
    Withdrawn
    Site US01080
    Salisbury, NC, United States, 28144
    Withdrawn
    Site CA15013
    Burlington, ON, Canada, L7N 3V2
    Completed
    Site US01060
    Kansas City, MO, United States, 64116
    Completed
    Site US01097
    Englewood, CO, United States, 80113
    Completed
    Site US01025
    Saint Petersburg, FL, United States, 33710
    Completed
    Site US01031
    Albuquerque, NM, United States, 87109
    Withdrawn
    Site GB44001
    Sheffield, United Kingdom, S10 2JF
    Withdrawn
    Site US01004
    Denver, CO, United States, 80220
    Completed
    Site PL48006
    Katowice, Poland, 40-611
    Withdrawn
    Site US01076
    Raleigh, NC, United States, 27609
    Withdrawn
    Site FR33008
    Limoges, France, 87042
    Withdrawn
    Site CA15007
    Granby, QC, Canada, J2G 8Z9
    Withdrawn
    Site US01050
    Dallas, TX, United States, 75390
    Completed
    Site GB44006
    York, United Kingdom, YO31 8HE
    Withdrawn
    Site US01039
    Greensboro, NC, United States, 27403
    Completed
    Site CZ42001
    Sternberk, Czech Republic, 78501
    Withdrawn
    Site US01008
    New York, NY, United States, 10016
    Completed
    Site US01094
    Shreveport, LA, United States, 71106
    Withdrawn
    Site US01006
    Jeffersonville, IN, United States, 47130
    Completed
    Site CA15001
    Brampton, ON, Canada, L6T 4S5
    Withdrawn
    Site US01018
    New York, NY, United States, 10065
    Withdrawn
    Site US01047
    Long Beach, CA, United States, 90806
    Withdrawn
    Site FR33005
    Paris Cedex 10, France, 75020
    Completed
    Site US01003
    Watertown, MA, United States, 02472
    Completed
    Site US01061
    Omaha, NE, United States, 68114
    Completed
    Site US01081
    Los Angeles, CA, United States, 90035
    Withdrawn
    Site US01065
    Raleigh, NC, United States, 27612
    Completed
    Site ES34009
    Lugo, Spain, 27003
    Withdrawn
    Site US01098
    Lancaster, PA, United States, 17604
    Completed
    Site US01016
    Boston, MA, United States, 02131
    Withdrawn
    Site US01001
    Concord, NC, United States, 28025

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

    Explore More

    1

    What are clinical trials?

    2

    Why are Clinical Trials Important?

    3

    Why Participate in a Clinical Trial?