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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00409357

First received: December 7, 2006

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: SL77.0499-10 (alfuzosin hydrochloride)	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Enlarged Prostate (BPH) Urine and Urination

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

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:

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.


Enrollment:	473
Study Start Date:	November 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409357

Locations


Japan
Sanofi-Aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	ICD CSD	Sanofi

More Information


Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00409357 History of Changes
Other Study ID Numbers:	DRI5234
Study First Received:	December 7, 2006
Last Updated:	October 1, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:


urinary tract

Additional relevant MeSH terms:


Hyperplasia Prostatic Hyperplasia Lower Urinary Tract Symptoms Pathologic Processes Prostatic Diseases Genital Diseases, Male Urological Manifestations Signs and Symptoms Alfuzosin	Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents

ClinicalTrials.gov processed this record on September 23, 2016

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