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.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: afuzosin

Primary Measures

• One year safety data of SL77.0499-10

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sanofi-Aventis

Overall Clinical Trial Officials and Contacts

Takashi TAKAGI Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00347061

Study ID Number: LTS5235

ClinicalTrials.gov Identifier: NCT00347061

Health Authority: Japan: Ministry of Health, Labor and Welfare