Lower Urinary Tract Symptoms, Prostatic Hyperplasia
Conditions
Keywords
Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Tamsulosin hydrochloride, Prostatic Hyperplasia
Brief summary
The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.
Detailed description
Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy. Other comparisons will be: Placebo and combination treatment. Solifenacin monotherapy and combination treatment
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male patients with LUTS associated with BPH diagnosed \> 3 months * IPSS score \> 13 * voiding and storage symptoms * maximum flow rate of \> 4 mL/s and \< 15 mL/s
Exclusion criteria
* post void residual volume \> 200 mL * symptomatic urinary tract infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride | 12 weeks |
Countries
Austria, Czechia, Denmark, Finland, France, Germany, Hungary, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, United Kingdom
Outcome results
None listed