A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Lower Urinary Tract Symptoms, Prostatic Hyperplasia

Intervention / Treatment
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* Drug: tamsulosin hydrochloride
* Drug: solifenacin succinate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: B<br> | Drug: solifenacin succinate<br>* antimuscarinic<br>|
| Active Comparator: C<br> | Drug: solifenacin succinate<br>* antimuscarinic<br>|
| Active Comparator: D<br> | Drug: solifenacin succinate<br>* antimuscarinic<br>|
| Active Comparator: E<br> | Drug: tamsulosin hydrochloride<br>* Alphablocker<br>|
| Active Comparator: F<br> | Drug: tamsulosin hydrochloride<br>* Alphablocker<br>Drug: solifenacin succinate<br>* antimuscarinic<br>|
| Active Comparator: G<br> | Drug: tamsulosin hydrochloride<br>* Alphablocker<br>Drug: solifenacin succinate<br>* antimuscarinic<br>|
| Active Comparator: H<br> | Drug: tamsulosin hydrochloride<br>* Alphablocker<br>Drug: solifenacin succinate<br>* antimuscarinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tamsulosin hydrochloride, Lower Urinary Tract Symptoms, Treatment, Solifenacin succinate, Prostatic Hyperplasia