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01
Overview
Phase 4, open-label, single-arm trial of alfuzosin in benign prostatic hyperplasia (BPH), sponsored by Sanofi. Primary endpoints: Spontaneous adverse events, Blood pressure and heart rate measured in sitting position and 5 more. Started Aug 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Alfuzosin 10 mg
Patients receiving Alfuzosin 10 mg once daily
03
Who it enrols
Ambulatory male patients with LUTS suggestive of BPH, excluding those requiring immediate surgery, those not improved by prior alpha-blockers, or those satisfactorily controlled on other BPH medications.
04
Endpoints
Primary
Spontaneous adverse events
Blood pressure and heart rate measured in sitting position
International Prostate Symptom Score and quality of life index
DAN-PSS sexual function score
PSA levels measured at baseline
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