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Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia

NCT00409357 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2009-10-02

No results posted yet for this study

Summary

The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH.

Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

SL77.0499-10 (alfuzosin hydrochloride)

Sponsors & Collaborators

Principal Investigators

  • ICD CSD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • Japan

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 NCT00409357 on ClinicalTrials.gov