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

Overview

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)

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Locations (79)

Outcomes