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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Silodosin

• Registration Number: NCT00224133
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Detailed Description

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)

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Results First Submitted: 2009-12-23
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-06
• Last Update Submitted: 2010-04-06
• Results First Posted: 2010-04-27
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 661

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Silodosin	Silodosin	Silodosin 8 mg per day with food

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.