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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224133
First received: September 14, 2005
Last updated: April 6, 2010
Last verified: April 2010
History of Changes

September 14, 2005
April 6, 2010
September 2005
April 2007   (final data collection date for primary outcome measure)
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.
Safety
Complete list of historical versions of study NCT00224133 on ClinicalTrials.gov Archive Site
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.
  • Change in baseline score on the International Prostate Symptom Score
  • Change in baseline urine flow rate
Not Provided
Not Provided
 
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

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

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)
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
Drug: Silodosin
8 mg daily
Other Name: Rapaflo
Experimental: Silodosin
Silodosin 8 mg per day with food
Intervention: Drug: Silodosin
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. Epub 2009 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
661
April 2007
April 2007   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00224133
SI04011
No
Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
Watson Pharmaceuticals
Not Provided
Study Director: Lawrence Hill, Pharm D, RPh Watson Pharmaceuticals
Watson Pharmaceuticals
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP