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A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate with 0.4 mg Tamsulosin Hydrochlorid...

Update Il y a 4 ans
Reference: EUCTR2007-001268-57

A Phase 2, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multi-Center Study to Evaluate the Safety of the Co-administration of Solifenacin Succinate with 0.4 mg Tamsulosin Hydrochloride OCAS (TOCAS) Using Urodynamics in Male Subjects with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

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Extract

The primary objective of this study is to evaluate the urodynamic variables of male subjects with LUTS and BOO treated with the co-administration of 6 mg solifenacin succinate and TOCAS, and 9 mg solifenacin succinate and tamsulosin OCAS versus placebo.

Inclusion criteria

  • Storage and Voiding Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

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