Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00399464

Purpose

The primary objective of the study is to demonstrate the superiority of SL77.0499-10 10mg once daily over placebo and the non-inferiority versus tamsulosin hydrochloride after 12 weeks treatment in terms of the efficacy in patients with lower urinary tract symptoms related to BPH.

The secondary objective is to assess the safety of SL77.0499-10 in patients with lower urinary tract symptoms related to BPH in comparison with placebo and tamsulosin hydrochloride.

Condition	Intervention	Phase
Prostatic Hyperplasia	Drug: alfuzosin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy and Safety of SL77.0499-10 10mg Once Daily in Comparison With Placebo and Tamsulosin Hydrochloride 0.2mg in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).

Resource links provided by NLM:

Drug Information available for: Alfuzosin hydrochloride Alfuzosin Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)

Secondary Outcome Measures:

Efficacy: Change in I-PSS total score from baseline to each visit
Change in Quality Of Life score from baseline to each visit
Change from baseline to endpoint of residual urine volume and urinary Peak Flow
Safety:Adverse events

Enrollment:	1177
Study Start Date:	November 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Japanese;
Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography within the last 6 months;
Suffering for at least 6 months from lower urinary tract symptoms related to BPH.

Exclusion Criteria:

Patients with mental disorders or who cannot be relied upon to understand the trial requirements and comply with the treatment regiment;
Inpatient;
Patients having participated in a clinical trial within the previous 6-month;
Patients previously treated with SL77.0499-10;
Patients whose I-PSS total score do not meet ≥ 13;
Patients whose urinary peak flow rate (PFR) do not meet 5.0-12.0mL/s for a voided volume of at least 150mL;
Patients whose residual urine are > 200mL;

The investigator will evaluate whether there are other reasons why a patient may not participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399464

Locations

Japan
Sanofi-aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5791
Study First Received:	November 13, 2006
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00399464 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Benign Prostatic Hyperplasia
Adrenergic alpha-Antagonists
alfuzosin

Additional relevant MeSH terms:

Neurotransmitter Agents
Prostatic Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Genital Diseases, Male
Pharmacologic Actions
Hyperplasia
Pathologic Processes
Alfuzosin
Prostatic Hyperplasia
Therapeutic Uses
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010