NCT01021332

Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, 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: 1,067 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Detailed description

This is an open-label extension study following the double blind 905-CL-055 study

Conditions

• Lower Urinary Tract Symptoms
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)	oral
DRUG	tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)	oral

Timeline

• Start date: 2010-04-26
• Primary completion: 2011-12-14
• Completion: 2011-12-14
• First posted: 2009-11-26
• Last updated: 2024-12-03
• Results posted: 2016-01-22

Locations

70 sites across 11 countries: Austria, Belarus, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Slovakia, United Kingdom