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

Phase 2

Completed

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT00409357
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 473

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan