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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Summary:

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)


Sponsor: Watson Pharmaceuticals

Current Primary Outcome: 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: Safety

Current Secondary Outcome: 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:

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


Information By: Watson Pharmaceuticals

Dates:
Date Received: September 14, 2005
Date Started: September 2005
Date Completion:
Last Updated: April 6, 2010
Last Verified: April 2010