The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
919
Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH
Time frame: 12 weeks
Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride
Time frame: 12 weeks
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Linz, North-West, Austria
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Graz, Styria, Austria
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Vienna, Vienna, Austria
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Ústí nad Labem, Czechia
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Aalborg, Denmark
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Frederiksberg, Denmark
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Roskilde, Denmark
...and 88 more locations