Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

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

Details

• Lead Sponsor: RECORDATI GROUP; Recordati Industria Chimica e Farmaceutica S.p.A.
• Treatments: Silodosin; Tamsulosin

Criteria

Inclusion Criteria:

• Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria:

• Medical conditions that would confound the efficacy evaluation

• Medical conditions in which it would be unsafe to use an alpha-blocker

• Use of concomitant drugs that would confound the efficacy evaluation

• Use of concomitant drugs that would be unsafe with this alpha-blocker