Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

Study Overview
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Brief Summary
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Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial

Official Title
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Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia : a Randomized, Double Blinded, Parallel Design, Active Controlled, Multi-center, Phase 3 Clinical Trial

Conditions
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Benign Prostate Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Solifenacin
* Drug: Solifenacin placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male aged 45 years old or older Subjects with benign prostatic hyperplasia diagnosed by digital rectal examination Subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form Exclusion Criteria: Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years Subjects who have acute urinary retention within 4 weeks before screening Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening Subjects who have hypersensitivity to investigational product or sulfa medications Subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,) Subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy Subjects who have cataract or glaucoma scheduled to be operated in the study duration. Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin + Solifenacin<br>Tamsulosin and Solifenacin | Drug: Tamsulosin<br>* Tamsulosin<br>Drug: Solifenacin<br>* Solifenacin<br>|
| Active Comparator: Tamsulosin + Solifenacin Placebo<br>Tamsulosin and Solifenacin placebo | Drug: Tamsulosin<br>* Tamsulosin<br>Drug: Solifenacin placebo<br>* Solifenacin placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of TUFS((Total Urgency and Frequency Score)/24h |  | From baseline at week 12 | 
| The change of total IPSS(International prostate symptom score) |  | From baseline at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of urgency/24h |  | From baseline at week 4, 8 and 12 | 
| The change of voiding frequency/24h |  | From baseline at week 4, 8 and 12 | 
| The change of nocturnal frequency/24h |  | From baseline at week 4, 8 and 12 | 
| The change of urge urinary incontinence frequency/24h |  | From baseline at week 4, 8 and 12 | 
| The change of IPSS(International prostate symptom score)-sub score |  | From baseline at week 4, 8 and 12 | 
| The change of PPBC(Patient perception of bladder condition) |  | From baseline at week 4 and 12 | 
| The change of IPSS(International prostate symptom score) QoL(Quality of Life) |  | From baseline at week 4, 8 and 12 | 
| PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change) |  | From baseline at week 12 | 
| The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4 |  | From baseline at week 12 |