Overview

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
Male
Summary
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
Phase:
Phase 2
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, with symptoms of moderate
to severe BPH and nocturia (>=2 episodes per night)

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.