Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (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

Interstitial Cystitis

Enuresis

Bladder Disorders

Treatment

tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)

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

Clinical Study ID

NCT01021332
905-CL-057
2008-001212-20
  • Ages > 45
  • Male

Study Summary

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion

Exclusion Criteria:

  • Any significant PVR volume (>150 mL)

Study Design

Total Participants: 1067
Treatment Group(s): 2
Primary Treatment: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
Phase: 3
Study Start date:
April 26, 2010
Estimated Completion Date:
December 14, 2011

Study Description

This is an open-label extension study following the double blind 905-CL-055 study

Connect with a study center

  • Innsbruck, 6020
    Austria

    Site Not Available

  • Vienna, 1090
    Austria

    Site Not Available

  • Minsk, 220119
    Belarus

    Site Not Available

  • Antwerp, 2020
    Belgium

    Site Not Available

  • Edegem, 2650
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Liege 1, 4000
    Belgium

    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

  • Roudnice nad Labem, 413 01
    Czechia

    Site Not Available

  • Uherske Hradiste, 686 08
    Czechia

    Site Not Available

  • Usti nad Labem, 400 01
    Czechia

    Site Not Available

  • Zd'ar nad Sazavou, 591 01
    Czechia

    Site Not Available

  • Colmar Cedex, 68024
    France

    Site Not Available

  • Montlucon, 03100
    France

    Site Not Available

  • Orleans cedex 2, 45067
    France

    Site Not Available

  • Paris, 75010
    France

    Site Not Available

  • Paris Cedex 10, 75020
    France

    Site Not Available

  • Pierre Benite, 69495
    France

    Site Not Available

  • Bautzen, 02625
    Germany

    Site Not Available

  • Frankfurt, 65933
    Germany

    Site Not Available

  • Ganderkesee, 27777
    Germany

    Site Not Available

  • Hagenow, 19230
    Germany

    Site Not Available

  • Halle Saale, 06132
    Germany

    Site Not Available

  • Hamburg, 20253
    Germany

    Site Not Available

  • Henningsdorf, 16761
    Germany

    Site Not Available

  • Hettstedt, 06333
    Germany

    Site Not Available

  • Koblenz, 56068
    Germany

    Site Not Available

  • Leipzig, 04105
    Germany

    Site Not Available

  • Lutherstadt Eisleben, 06295
    Germany

    Site Not Available

  • Neustadt in Sachsen, 01844
    Germany

    Site Not Available

  • Radebeul, 01445
    Germany

    Site Not Available

  • Sachsen, 06526
    Germany

    Site Not Available

  • Trier, 54290
    Germany

    Site Not Available

  • Uetersen, 25436
    Germany

    Site Not Available

  • Avellino, 83100
    Italy

    Site Not Available

  • Catanzaro, 88100
    Italy

    Site Not Available

  • Palermo, 90146
    Italy

    Site Not Available

  • Treviglio, 24047
    Italy

    Site Not Available

  • Amsterdam, 100 AD
    Netherlands

    Site Not Available

  • Apeldoorn, 7334 DZ
    Netherlands

    Site Not Available

  • Doetinchem, 7009 BL
    Netherlands

    Site Not Available

  • Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Sneek, 8600 BA
    Netherlands

    Site Not Available

  • Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • Winterswijk, 7101 BN
    Netherlands

    Site Not Available

  • Bielsko-Biala, 43-300
    Poland

    Site Not Available

  • Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Krakow, 31-530
    Poland

    Site Not Available

  • Pulawy, 24-100
    Poland

    Site Not Available

  • Warsaw, 02-005
    Poland

    Site Not Available

  • Wiecbork, 89-410
    Poland

    Site Not Available

  • Nitra, 949 01
    Slovakia

    Site Not Available

  • Piestany, 921 02
    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

  • Cardiff, CF14 5GJ
    United Kingdom

    Site Not Available

  • Chorley, PR7 7NA
    United Kingdom

    Site Not Available

  • Liverpool, L22 0LG
    United Kingdom

    Site Not Available

  • Northwood, HA6 2RN
    United Kingdom

    Site Not Available

  • Oxford, OX3 7LJ
    United Kingdom

    Site Not Available

  • Reading, RG2 7AG
    United Kingdom

    Site Not Available

  • Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Taunton, TA1 5DA
    United Kingdom

    Site Not Available

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