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
  • 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 patient
    • A caregiver
    • A parent
    • A healthcare provider
    • 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?