drugset / Trial / NCT00540891

The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score

NCT00540891

Phase 3 Completed 372 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary: Evaluate the safety and onset of symptom relief using an acute I-PSS form (7 day form). Determine onset of urinary peak flow improvement after 7 days Secondary: Determine improvement in Bother Score after 7 \& 28 days; improvement in sexual function after 28 days; assess one-month efficacy and safety

Timeline

Start
2003-02
Primary completion
Completion
2004-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Alfuzosin Small molecule