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

• ClinicalTrials.gov Identifier: NCT00224133
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: April 27, 2010
• Last Update Posted: April 27, 2010
• Sponsor: Watson Pharmaceuticals
• Information provided by: Watson Pharmaceuticals

Tracking Information

• First Submitted Date: September 14, 2005
• First Posted Date: September 22, 2005
• Results First Submitted Date: December 23, 2009
• Results First Posted Date: April 27, 2010
• Last Update Posted Date: April 27, 2010
• Study Start Date: September 2005
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2010)

Adverse Events [ Time Frame: 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.

• Original Primary Outcome Measures (submitted: September 14, 2005): Safety

Current Secondary Outcome Measures (submitted: April 6, 2010)

International Prostate Symptom Score (IPSS) [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: September 14, 2005)

• Change in baseline score on the International Prostate Symptom Score
• Change in baseline urine flow rate

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
• 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
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Benign Prostatic Hyperplasia

Intervention

Drug: Silodosin

8 mg daily

Other Name: Rapaflo

Study Arms

Experimental: Silodosin

Silodosin 8 mg per day with food

Intervention: Drug: Silodosin

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 17, 2007): 661
• Original Enrollment (submitted: September 14, 2005): 1200
• Actual Study Completion Date: April 2007
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00224133
• Other Study ID Numbers: SI04011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
• Study Sponsor: Watson Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Lawrence Hill, Pharm D, RPh; Watson Pharmaceuticals

• PRS Account: Watson Pharmaceuticals
• Verification Date: April 2010