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

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)

• Silodosin (Drug), also known as Rapaflo: 8 mg daily

Primary outcomes

• Adverse Events [9 months]: All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.

Secondary outcomes

• International Prostate Symptom Score (IPSS) [9 months]: 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.

Sex: Male, ages: 50 Years to any

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.

Participant flow

Outcome results

• Adverse Events (Primary), Number, participants: 8 mg Silodosin Per Day With Food 431
• International Prostate Symptom Score (IPSS) (Secondary), Mean, Units on a scale

Adverse events

Time frame: 9 months

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 19815265

• Lawrence Hill, Pharm D, RPh, Study director, Watson Pharmaceuticals