Benign Prostatic Hyperplasia
Conditions
Keywords
urinary tract
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 the efficacy in patients with lower urinary tract symptoms (LUTS) related to BPH. Secondary objectives are to assess the efficacy of each dose of alfuzosin as compared with placebo and to assess the safety of each dose of alfuzosin.
Interventions
DRUGSL77.0499-10 (alfuzosin hydrochloride)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy assessment is the change from baseline in International Prostate Symptom Score (IPSS) total score at the end-of-study (EOS) visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: changes from baseline in IPSS total score by visit;·IPSS irritative and obstructive subscores,·urinary peak flow rate and residual urine volume at EOS and by visit. | — |
| Safety: adverse events, vital signs, laboratory tests. | — |
Countries
Japan
Outcome results
None listed