Status:
COMPLETED
Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia
Lead Sponsor:
Sanofi
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess the dose-response relationship of SL77.0499 10 (alfuzosin hydrochloride) 5 mg, 10 mg, 15 mg, and placebo once daily during a 12-week oral administration period for t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- suffering from LUTS related to BPH for at least 6 months;
- having an IPSS \>13;
- having a urinary peak flow rate 5.0 to 12.0 mL/s for a voided volume of at least 150 mL;
- having a residual urine volume \< or = 200 mL.
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
473 Patients enrolled
Trial Details
Trial ID
NCT00409357
Start Date
November 1 2004
End Date
August 1 2005
Last Update
October 2 2009
Active Locations (1)
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1
Sanofi-Aventis
Tokyo, Japan