A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
NCT ID: NCT00510406
Last Updated: 2014-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
919 participants
INTERVENTIONAL
2007-01-31
2007-09-30
Brief Summary
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Detailed Description
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The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.
Other comparisons will be:
Placebo and combination treatment. Solifenacin monotherapy and combination treatment
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Placebo
Placebo
B
solifenacin succinate
antimuscarinic
C
solifenacin succinate
antimuscarinic
D
solifenacin succinate
antimuscarinic
E
tamsulosin hydrochloride
Alphablocker
F
tamsulosin hydrochloride
Alphablocker
solifenacin succinate
antimuscarinic
G
tamsulosin hydrochloride
Alphablocker
solifenacin succinate
antimuscarinic
H
tamsulosin hydrochloride
Alphablocker
solifenacin succinate
antimuscarinic
Interventions
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tamsulosin hydrochloride
Alphablocker
solifenacin succinate
antimuscarinic
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* IPSS score \> 13
* voiding and storage symptoms
* maximum flow rate of \> 4 mL/s and \< 15 mL/s
Exclusion Criteria
* symptomatic urinary tract infection
45 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Linz, North-West, Austria
Graz, Styria, Austria
Vienna, Vienna, Austria
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Aalborg, , Denmark
Frederiksberg, , Denmark
Roskilde, , Denmark
Skejby, , Denmark
Helsinki, , Finland
Kuopio, , Finland
Lahti, , Finland
Oulu, , Finland
Tampere, , Finland
Colmar, , France
Cote de Nacre, , France
Créteil, , France
Marseille, , France
Montluçon, , France
Mulhouse, , France
Nîmes, , France
Paris, , France
Ploemeur, , France
Bad Segeberg, , Germany
Bamberg, , Germany
Bautzen, , Germany
Dresden, , Germany
Eisleben Lutherstadt, , Germany
Ganderkessee, , Germany
Hagenow, , Germany
Halle, , Germany
Hamburg, , Germany
Henningsdorf, , Germany
Hettstedt, , Germany
Koblenz, , Germany
Leipzig, , Germany
München, , Germany
Münster, , Germany
Neustadt in Sachsen, , Germany
Trier, , Germany
Uetersen, , Germany
Budapest, , Hungary
Eger, , Hungary
Miskolc, , Hungary
Nyiregyháza, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Szekszárd, , Hungary
Tatabánya, , Hungary
Nijmegen, Gelderland, Netherlands
Maastricht, Limburg, Netherlands
S'Hertogenbosch, North Brabant, Netherlands
Tilburg, North Brabant, Netherlands
Amsterdam, North Holland, Netherlands
Apeldoorn, Overijssel, Netherlands
Deventer, Overijssel, Netherlands
Sneek, Provincie Friesland, Netherlands
Utrecht, Utrecht, Netherlands
Fredrikstad, , Norway
Oslo, , Norway
Tønsberg, , Norway
Bialystok, , Poland
Bydgoszcz, , Poland
Katowice, , Poland
Krakow, , Poland
Lódz, , Poland
Lublin, , Poland
Puławy, , Poland
Szczecin, , Poland
Warsaw, , Poland
Amadora-Sintra, , Portugal
Carmo, , Portugal
Coimbra (Covões), , Portugal
Orta EPE, , Portugal
Pulido Valente, , Portugal
Santa Luzia, , Portugal
Tomar, , Portugal
Moscow, , Russia
Saint Petersburg, , Russia
Nitra, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
A Coruña, , Spain
Barcelona, , Spain
Madrid, , Spain
Pontevedra, , Spain
Seville, , Spain
Kungälv, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Uddevalla, , Sweden
Uppsala, , Sweden
Reading, Berkshire, United Kingdom
Chorley, Lancashire, United Kingdom
Cardiff, Wales, United Kingdom
Swansea, Wales, United Kingdom
Countries
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References
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Van Kerrebroeck P, Haab F, Angulo JC, Vik V, Katona F, Garcia-Hernandez A, Klaver M, Traudtner K, Oelke M. Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Eur Urol. 2013 Sep;64(3):398-407. doi: 10.1016/j.eururo.2013.03.031. Epub 2013 Mar 19.
Other Identifiers
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EudraCT number: 2006-002072-18
Identifier Type: -
Identifier Source: secondary_id
905-CL-052
Identifier Type: -
Identifier Source: org_study_id
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