Status:
COMPLETED
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Nocturia
Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief 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
Detailed Description
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00793819
Start Date
January 1 2009
End Date
October 1 2009
Last Update
March 9 2012
Active Locations (27)
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1
Watson Investigational Site
Huntsville, Alabama, United States
2
Watson Investigational Site
Laguna Hills, California, United States
3
Watson Investigational Site
San Diego, California, United States
4
Watson Investigational Site
Aventura, Florida, United States