Study summary

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

Additional Study Details

Phase
3
Product
  • Placebo tamsulosin hydrochloride OCAS 0.4 mg
  • Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg
  • Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
  • tamsulosin hydrochloride OCAS 0.4 mg
  • tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
  • tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
  • Type
    Interventional
    Masking
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Enrollment number
    1334
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for Study of solifenacin succinate and tamsulosin hydrochloride OCAS in males with lower urinary tract symptoms? Contact us by filling out your information to the right and we’ll respond to you.

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    • 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
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    • India
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      Locations

      Contact Us
      Contact Us
      Completed
      Doetinchem, Netherlands, 7009 BL
      Completed
      Vienna, Austria, 1090
      Completed
      Sopron, Hungary, 9400
      Completed
      Wiecbork, Poland, 89-410
      Completed
      Prague, Czech Republic, 180 81
      Completed
      Tours Cedex, France, 37044
      Completed
      Henningsdorf, Germany, 16761
      Completed
      Assebroek, Belgium, 8310
      Completed
      Northwood, United Kingdom, HA6 2RN
      Completed
      Salzburg, Austria, 5020
      Completed
      Krakow, Poland, 31-530
      Withdrawn
      Novara, Italy, 28100
      Completed
      Gent, Belgium, 9000
      Completed
      Sint-Truiden, Belgium, 3800
      Withdrawn
      Szeged, Hungary, 6725
      Completed
      Rennes, France, 35033
      Completed
      Edegem, Belgium, 2650
      Completed
      Florence, Italy, 50139
      Completed
      Neustadt in Sachsen, Germany, 01844
      Completed
      Zdar nad Sazavou, Czech Republic, 591 01
      Completed
      Turin, Italy, 10154
      Completed
      Leuven, Belgium, 3000
      Completed
      Bristol, United Kingdom, BS10 5NB
      Completed
      Torquay, United Kingdom, TQ2 7AA
      Completed
      Moscow, Russian Federation, 125206
      Completed
      St. Petersburg, Russian Federation, 197089
      Completed
      Plymouth, United Kingdom, PL6 8DH
      Completed
      Minsk, Belarus, 220119
      Completed
      Hamburg, Germany, 20253
      Completed
      Antwerp, Belgium, 2030
      Completed
      Plzen, Czech Republic, 301 24
      Completed
      Maastricht, Netherlands, 6229 HX
      Completed
      Brussels, Belgium, 1090
      Completed
      Ostrava, Czech Republic, 700 30
      Completed
      Skalica, Slovakia, 909 82
      Completed
      Palermo, Italy, 90146
      Completed
      Colmar Cedex, France, 68024
      Completed
      Paris, France, 75010
      Completed
      Eindhoven, Netherlands, 5623 EJ
      Completed
      Glasgow, United Kingdom, G81 2DR
      Completed
      Szentes, Hungary, 6601
      Completed
      Moscow, Russian Federation, 111020
      Completed
      Hradec Kralove, Czech Republic, 500 02
      Completed
      Glasgow, United Kingdom, G20 0XA
      Completed
      Dijon, France, 21079
      Withdrawn
      Paris Cedex 13, France, 75634
      Completed
      Bielsko Biala, Poland, 43-300
      Withdrawn
      Lodz, Poland, 90-549
      Withdrawn
      Portogruaro, Italy, 300026
      Completed
      Liege 1, Belgium, 4000
      Completed
      Cardiff, United Kingdom, CF14 5GJ
      Withdrawn
      Salgotarjan, Hungary, 3100
      Completed
      Presov, Slovakia, 080 01
      Completed
      Reading, United Kingdom, RG2 7AG
      Withdrawn
      Paris Cedex 12, France, 75571
      Completed
      Angers, France, 49033
      Completed
      Halle Saale, Germany, 06132
      Completed
      Manchester, United Kingdom, M15 6SX
      Completed
      Budapest, Hungary, 1204
      Completed
      Warsaw, Poland, 02-005
      Completed
      Paris Cedex 10, France, 75020
      Completed
      Chorley, United Kingdom, PR7 7NA
      Completed
      Turnhout, Belgium, 2300
      Completed
      Aix en Provence, France, 13616
      Completed
      Bydgoszcz, Poland, 85-094
      Completed
      Lutherstadt Eisleben, Germany, 06295
      Completed
      Catanzaro, Italy, 88100
      Completed
      Usti nad Labem, Czech Republic, 40001
      Completed
      Avellino, Italy, 83100
      Completed
      Bari, Italy, 70124
      Completed
      Dijon, France, 21000
      Completed
      Brussels, Belgium, 1070
      Completed
      Roudnice nad Labem, Czech Republic, 413 01
      Completed
      Liverpool, United Kingdom, L22 0LG
      Completed
      Bergamo, Italy, 24125
      Completed
      Pierre Benite, France, 69495
      Completed
      Birmingham, United Kingdom, B15 2SQ
      Completed
      Antwerp, Belgium, 2020
      Completed
      Taunton, United Kingdom, TA1 5DA
      Completed
      Reading, United Kingdom, RG1 5AN
      Completed
      Orleans Cedex 2, France, 45067
      Completed
      Bautzen, Germany, 02625
      Completed
      Leipzig, Germany, 04105
      Completed
      Tilburg, Netherlands, 5022 GC
      Withdrawn
      Chieti, Italy, 66100
      Completed
      Lyon Cedex 3, France, 69437
      Completed
      Paris Cedex 14, France, 75679
      Completed
      Sneek, Netherlands, 8600 BA
      Completed
      Nottingham, United Kingdom, NG5 1PB
      Completed
      Pulawy, Poland, 24-100
      Completed
      Bristol, United Kingdom, BS2 8HW
      Completed
      Treviglio, Italy, 24047
      Completed
      Trencin, Slovakia, 911 01
      Completed
      Catania, Italy, 95124
      Completed
      Kortrijk, Belgium, 8500
      Completed
      Uherske Hradiste, Czech Republic, 686 08
      Withdrawn
      Budapest, Hungary, H-1106
      Completed
      Minsk, Belarus, 220036
      Completed
      Frankfurt, Germany, 65933
      Completed
      Szekszard, Hungary, 7100
      Completed
      Leipzig, Germany, 04109
      Withdrawn
      Udine, Italy, 33100
      Completed
      Brussels, Belgium, 1200
      Completed
      Innsbruck, Austria, 6020
      Completed
      Sheffield, United Kingdom, S10 2JF
      Completed
      Apeldoorn, Netherlands, 7334 DZ
      Completed
      Bad Ems, Germany, 56130
      Completed
      Koblenz, Germany, 56068
      Completed
      Tatabanya, Hungary, 2800
      Completed
      Reading, United Kingdom, RG2 0TG
      Completed
      Montlucon, France, 03100
      Completed
      Kormend, Hungary, 9900
      Withdrawn
      Morriston, United Kingdom
      Completed
      Nitra, Slovakia, 949 01
      Completed
      Winterswijk, Netherlands, 7101 BN
      Withdrawn
      Moscow, Russian Federation, 105425
      Withdrawn
      Toulon, France, 83100
      Withdrawn
      Enschede, Netherlands, 7511 JX
      Completed
      Sneek, Netherlands, 8601 ZK
      Completed
      Hagenow, Germany, 19230
      Withdrawn
      Prague 2, Czech Republic, 128 08
      Completed
      Nyiregyhaza, Hungary, 4400
      Completed
      Hettstedt, Germany, 06333
      Completed
      Amsterdam, Netherlands, 1100 AD
      Completed
      Uetersen, Germany, 25436
      Completed
      Zilina, Slovakia
      Completed
      Etten-Leur, Netherlands, 4872 LA
      Withdrawn
      Turin, Italy, 10126
      Completed
      Moscow, Russian Federation, 119435
      Completed
      Piestany, Slovakia, 921 01
      Completed
      Bordeaux Cedex, France, 33076

      Frequently Asked Questions

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      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.

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      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.

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