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

Prostatic Hyperplasia Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399464
• Other study ID #: EFC5791
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2006
• Last updated: October 1, 2009
• Start date: November 2006
• Est. completion date: October 2007

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1177
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• alfuzosin

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	Change in I-PSS (International Prostate Symptom Score) total score from baseline to endpoint (Day 84 or last available post-baseline assessment)
Secondary	Efficacy: Change in I-PSS total score from baseline to each visit
Secondary	Change in Quality Of Life score from baseline to each visit
Secondary	Change from baseline to endpoint of residual urine volume and urinary Peak Flow
Secondary	Safety:Adverse events