A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Overview
- Phase
- Phase 2
- Intervention
- tamsulosin hydrochloride
- Conditions
- Lower Urinary Tract Symptoms
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 919
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
H
Intervention: tamsulosin hydrochloride
A
Intervention: Placebo
B
Intervention: solifenacin succinate
C
Intervention: solifenacin succinate
D
Intervention: solifenacin succinate
E
Intervention: tamsulosin hydrochloride
F
Intervention: tamsulosin hydrochloride
F
Intervention: solifenacin succinate
G
Intervention: tamsulosin hydrochloride
G
Intervention: solifenacin succinate
H
Intervention: solifenacin succinate
Outcomes
Primary Outcomes
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
Time Frame: 12 weeks
Secondary Outcomes
- Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride(12 weeks)