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

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT00347061
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-01
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 148

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
One year safety data of SL77.0499-10

Secondary Outcome Measures

Name	Time	Method
One year efficacy data and plasma concentration of SL77.0499-10

Trial Locations

Locations (1)

Sanofi-Aventis; 🇯🇵 Tokyo, Japan