A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
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Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
Condition or disease
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 are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life
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Ages Eligible for Study:
50 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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.