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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2007-10-08

No results posted yet for this study

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

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

ALFUZOSIN

Sponsors & Collaborators

Principal Investigators

  • Yasir Nagarwala, M.D. · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Completion
2004-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00540891 on ClinicalTrials.gov