The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Adverse Events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events.
- International Prostate Symptom Score (IPSS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Silodosin 8 mg per day with food
8 mg daily
Other Name: Rapaflo
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)
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|Study Director:||Lawrence Hill, Pharm D, RPh||Watson Pharmaceuticals|