NCT00507455

Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Conditions

• Lower Urinary Tract Symptoms
• Bladder Outlet Obstruction

Interventions

Type	Name	Description
DRUG	solifenacin succinate	Solifenacin succinate tablets
DRUG	tamsulosin hydrochloride	Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets
DRUG	Placebo to solifenacin
DRUG	Placebo to tamsulosin

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-07-26
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

33 sites across 6 countries: United States, Belgium, Czechia, Germany, Hungary, Poland