The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

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

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Silodosin

Criteria

Inclusion Criteria:

• Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010.

Exclusion Criteria:

• Medical conditions that would confound the efficacy evaluation.

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

• The use of concomitant drugs that would confound the efficacy evaluation.

• The use of concomitant drugs that would be unsafe with this alpha-blocker.