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

Sanofi473 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

473

Conditions

Benign Prostatic Hyperplasia

Interventions

SL77.0499-10 (alfuzosin hydrochloride)DRUG

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sanofi-Aventis

Tokyo, Japan

Outcomes

Primary Outcomes

The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit.

Secondary Outcomes

Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit.

Safety: adverse events, vital signs, laboratory tests.

Data from ClinicalTrials.gov

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