A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• male patients with LUTS associated with BPH diagnosed > 3 months

• IPSS score > 13

• voiding and storage symptoms

• maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion Criteria:

• post void residual volume > 200 mL

• symptomatic urinary tract infection