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

A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance. All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.

The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms.

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.

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318-22. doi: 10.1016/j.urology.2009.06.072. Epub 2009 Oct 7.