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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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SL77.0499-10 (alfuzosin hydrochloride)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* suffering from LUTS related to BPH for at least 6 months;
* having an IPSS \>13;
* having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
* having a residual urine volume \< or = 200 mL.

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No