Clinical Trial: A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

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

Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Pr

Brief Summary: A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed Summary: This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in 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, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
Sponsor: Watson Pharmaceuticals

Current Primary Outcome: International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]

Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms


Original Primary Outcome: Change in baseline score on the International Prostate Symptom Score

Current Secondary Outcome: Maximum Urine Flow Rate (Qmax) [ Time Frame: 12 weeks ]

Change from baseline in maximum urine flow rate (Qmax)at Week 12


Original Secondary Outcome: Change in baseline urine flow rate Safety

Information By: Watson Pharmaceuticals

Dates:
Date Received: September 14, 2005
Date Started: May 2005
Date Completion:
Last Updated: July 5, 2011
Last Verified: July 2011