NCT00771394

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 638 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Tamsulosin hydrochloride	oral
DRUG	Solifenacin succinate	oral

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-10-13
• Last updated: 2013-02-15

Locations

8 sites across 1 country: Japan