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

NCT00399464 | Completed Phase 3

• 1 other identifier: EFC5791
• Study Type: interventional
• Target: 1,177
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Adrenergic alpha-Antagonists; alfuzosin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Interventions

alfuzosin DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 2, 2009

Record last verified: 2009-10

Locations

JP (1)