NCT00510406

A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 919 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	tamsulosin hydrochloride	Alphablocker
DRUG	solifenacin succinate	antimuscarinic
DRUG	Placebo	Placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-08-02
• Last updated: 2014-08-20

Locations

98 sites across 16 countries: Austria, Czechia, Denmark, Finland, France, Germany, Hungary, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, United Kingdom