Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Solifenacin Succinate; Tamsulosin

Criteria

Inclusion Criteria:

• Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months

• A total International Prostate Symptom Score (IPSS) of ≥13

• A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow

• A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion Criteria:

• Any significant Post Void Residual volume (>150 mL)

• A prostate with estimated weight ≥75 ml as assessed by transvesical or transrectal ultrasound

• Evidence of a symptomatic urinary tract infection