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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose Ranging Study of SL77.0499-10 Once Daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409357
• Other study ID #: DRI5234
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2006
• Last updated: October 1, 2009
• Start date: November 2004
• Est. completion date: August 2005

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• SL77.0499-10 (alfuzosin hydrochloride)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Safety: adverse events, vital signs, laboratory tests.