Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

Benign Prostatic Hyperplasia Clinical Trial

Official title:

A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347061
• Other study ID #: LTS5235
• Status: Completed
• Phase: Phase 3
• First received: June 30, 2006
• Last updated: October 1, 2009
• Start date: May 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

Primary:

To assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.

Secondary:

• To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.

• To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• 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:

• Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography

• Suffering for at least 6 months from lower urinary tract symptoms related to BPH

• An I-PSS total score = 13

• Out patient

Exclusion Criteria:

• Patients previously treated with SL77.0499-10.

• Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.

• Isolated bladder neck disease.

• Diagnosed carcinoma of the prostate.

• Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.

• Patients having an indwelling catheter.

• A residual urine > 200mL.

• Patients with Moderate or sever hepatic insufficiency.

• Known hypersensitivity to alpha1-blockers.

• Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening

• Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• afuzosin

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	One year safety data of SL77.0499-10
Secondary	One year efficacy data and plasma concentration of SL77.0499-10