Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Overactive Bladder Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride

Status Completed

Clinical Trial Summary

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Clinical Trial Description

Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Hyperplasia
• Hypertrophy
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

• NCT number: NCT00771394
• Study type: Interventional
• Source: Astellas Pharma Inc
• Status: Completed
• Phase: Phase 4
• Start date: October 2008
• Completion date: January 2010