NCT01018511

Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,334 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

Conditions

• Benign Prostatic Hyperplasia
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DRUG	Placebo tamsulosin hydrochloride OCAS 0.4 mg	tablet
DRUG	Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg	tablet
DRUG	Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg	tablet
DRUG	tamsulosin hydrochloride OCAS 0.4 mg	tablet
DRUG	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)	tablet
DRUG	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)	tablet

Timeline

• Start date: 2010-01-11
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-11-23
• Last updated: 2024-12-03
• Results posted: 2015-12-17

Locations

118 sites across 13 countries: Austria, Belarus, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Russia, Slovakia, United Kingdom