Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

Last updated: November 12, 2024
Sponsor: Astellas Pharma Europe B.V.
Overall Status: Completed

Phase

3

Condition

Bladder Disorders

Interstitial Cystitis

Enuresis

Treatment

Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg

Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg

tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)

Clinical Study ID

NCT01018511
905-CL-055
2008-001211-37
  • Ages > 45
  • Male

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months

  • A total International Prostate Symptom Score (IPSS) of ≥13

  • A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120mL during free flow

  • A micturition frequency of ≥8 and at least 2 episodes of urgency with PatientPerception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion

Exclusion Criteria:

  • Any significant Post Void Residual volume (>150 mL)

  • A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectalultrasound

  • Evidence of a symptomatic urinary tract infection

Study Design

Total Participants: 1334
Treatment Group(s): 6
Primary Treatment: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg
Phase: 3
Study Start date:
January 11, 2010
Estimated Completion Date:
March 01, 2011

Connect with a study center

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Salzburg, 5020
    Austria

    Site Not Available

  • Vienna, 1090
    Austria

    Site Not Available

  • Minsk, 220119
    Belarus

    Site Not Available

  • Antwerp, 2030
    Belgium

    Site Not Available

  • Assebroek, 8310
    Belgium

    Site Not Available

  • Brussels, 1200
    Belgium

    Site Not Available

  • Edegem, 2650
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Kortrijk, 8500
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Liege 1, 4000
    Belgium

    Site Not Available

  • Sint-Truiden, 3800
    Belgium

    Site Not Available

  • Turnhout, 2300
    Belgium

    Site Not Available

  • Hradec Kralove, 500 02
    Czech Republic

    Site Not Available

  • Ostrava, 700 30
    Czech Republic

    Site Not Available

  • Plzen, 301 24
    Czech Republic

    Site Not Available

  • Prague, 180 81
    Czech Republic

    Site Not Available

  • Roudnice nad Labem, 413 01
    Czech Republic

    Site Not Available

  • Uherske Hradiste, 686 08
    Czech Republic

    Site Not Available

  • Usti nad Labem, 40001
    Czech Republic

    Site Not Available

  • Zdar nad Sazavou, 591 01
    Czech Republic

    Site Not Available

  • Hradec Kralove, 500 02
    Czechia

    Site Not Available

  • Ostrava, 700 30
    Czechia

    Site Not Available

  • Plzen, 301 24
    Czechia

    Site Not Available

  • Prague, 180 81
    Czechia

    Site Not Available

  • Roudnice nad Labem, 413 01
    Czechia

    Site Not Available

  • Uherske Hradiste, 686 08
    Czechia

    Site Not Available

  • Usti nad Labem, 40001
    Czechia

    Site Not Available

  • Zdar nad Sazavou, 591 01
    Czechia

    Site Not Available

  • Aix en Provence, 13616
    France

    Site Not Available

  • Angers, 49033
    France

    Site Not Available

  • Bordeaux Cedex, 33076
    France

    Site Not Available

  • Colmar Cedex, 68024
    France

    Site Not Available

  • Dijon, 21000
    France

    Site Not Available

  • Lyon Cedex 3, 69437
    France

    Site Not Available

  • Montlucon, 03100
    France

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  • Orleans Cedex 2, 45067
    France

    Site Not Available

  • Paris, 75010
    France

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  • Paris Cedex 10, 75020
    France

    Site Not Available

  • Paris Cedex 14, 75679
    France

    Site Not Available

  • Pierre Benite, 69495
    France

    Site Not Available

  • Rennes, 35033
    France

    Site Not Available

  • Tours Cedex, 37044
    France

    Site Not Available

  • Bad Ems, 56130
    Germany

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  • Bautzen, 02625
    Germany

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  • Frankfurt, 65933
    Germany

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  • Hagenow, 19230
    Germany

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  • Halle Saale, 06132
    Germany

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  • Hamburg, 20253
    Germany

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  • Henningsdorf, 16761
    Germany

    Site Not Available

  • Hettstedt, 06333
    Germany

    Site Not Available

  • Koblenz, 56068
    Germany

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  • Leipzig, 04109
    Germany

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  • Lutherstadt Eisleben, 06295
    Germany

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  • Neustadt in Sachsen, 01844
    Germany

    Site Not Available

  • Uetersen, 25436
    Germany

    Site Not Available

  • Budapest, 1204
    Hungary

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  • Kormend, 9900
    Hungary

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  • Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Sopron, 9400
    Hungary

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  • Szekszard, 7100
    Hungary

    Site Not Available

  • Szentes, 6601
    Hungary

    Site Not Available

  • Tatabanya, 2800
    Hungary

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  • Avellino, 83100
    Italy

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  • Bari, 70124
    Italy

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  • Bergamo, 24125
    Italy

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  • Catania, 95124
    Italy

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  • Catanzaro, 88100
    Italy

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  • Florence, 50139
    Italy

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  • Palermo, 90146
    Italy

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  • Treviglio, 24047
    Italy

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  • Turin, 10154
    Italy

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  • Amsterdam, 1100 AD
    Netherlands

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  • Apeldoorn, 7334 DZ
    Netherlands

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  • Doetinchem, 7009 BL
    Netherlands

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  • Eindhoven, 5623 EJ
    Netherlands

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  • Etten-Leur, 4872 LA
    Netherlands

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  • Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Sneek, 8601 ZK
    Netherlands

    Site Not Available

  • Tilburg, 5022 GC
    Netherlands

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  • Winterswijk, 7101 BN
    Netherlands

    Site Not Available

  • Bielsko Biala, 43-300
    Poland

    Site Not Available

  • Bydgoszcz, 85-094
    Poland

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  • Krakow, 31-530
    Poland

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  • Pulawy, 24-100
    Poland

    Site Not Available

  • Warsaw, 02-005
    Poland

    Site Not Available

  • Wiecbork, 89-410
    Poland

    Site Not Available

  • Moscow, 125206
    Russian Federation

    Site Not Available

  • St. Petersburg, 198013
    Russian Federation

    Site Not Available

  • Nitra, 949 01
    Slovakia

    Site Not Available

  • Piestany, 921 01
    Slovakia

    Site Not Available

  • Presov, 080 01
    Slovakia

    Site Not Available

  • Skalica, 909 82
    Slovakia

    Site Not Available

  • Trencin, 911 01
    Slovakia

    Site Not Available

  • Zilina,
    Slovakia

    Site Not Available

  • Birmingham, B15 2SQ
    United Kingdom

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  • Bristol, BS10 5NB
    United Kingdom

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  • Cardiff, CF14 5GJ
    United Kingdom

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  • Chorley, PR7 7NA
    United Kingdom

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  • Glasgow, G20 0XA
    United Kingdom

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  • Liverpool, L22 0LG
    United Kingdom

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  • Manchester, M15 6SX
    United Kingdom

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  • Northwood, HA6 2RN
    United Kingdom

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  • Nottingham, NG5 1PB
    United Kingdom

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  • Plymouth, PL6 8DH
    United Kingdom

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  • Reading, RG2 7AG
    United Kingdom

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  • Sheffield, S10 2JF
    United Kingdom

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  • Taunton, TA1 5DA
    United Kingdom

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  • Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

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