A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia

• Status: Completed
• Trial end date: 2014-04-04
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tamsulosin

Criteria

Inclusion Criteria:

• dysuria associated with BPH for at least 12 weeks before providing consent

• a total IPSS core of 13 or higher

• a QOL score of 3 or higher

• a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec.

• a prostate volume of ≥20 mL.

Exclusion Criteria:

• A postvoid residual volume (PVR) of >350 mL

• A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study

• A cataract operation scheduled to be performed during the study period

• Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study

• Hypersensitivity to ASP4901 or tamsulosin hydrochloride

• Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant