Status:
COMPLETED
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
Lead Sponsor:
Sanofi
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00347061
Start Date
May 1 2006
End Date
October 1 2007
Last Update
October 2 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan