Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS

Study Overview
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Brief Summary
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Study to investigate the efficacy and safety of GL2702 GLARS-NF1tablet and Harnal-D - tablet in benign prostatic hyperplasia patients with lower urinary tract symptomatic

Detailed Description
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GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech

Official Title
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A Multicenter, Randomized, Double -Blind, Parallel, Comparative, Phase III Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1 Tablet in BPH Patients With LUTS

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin HCL 0.4mg
* Drug: Tamsulosin HCL 0.2mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 50 years old, BPH diagnosted, Adult Male Subject IPSS ≥ 13 point PSA < 4ng/mL 5ml/sec < Qmax ≤ 15ml/sec Exclusion Criteria: Prostatic cancer 250ml < PVR ALT or AST > 2 times (Upper Normal Range) Total Bilirubin > 1.5 times (Upper Normal Range) Treated with α-adrenalin receptor blocker within 2weeks before screening Treated with 5Alpha-Reductase Inhibitor within 6 months before screening Treated with phytotherapy within 2weeks before screening Treated with Anabolic Steroid within 6 months before screening

Ages Eligible for Study
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Minimum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin HCL 0.2mg<br>Harnal-D tablet (Tamsulosin HCL 0.2mg) | Drug: Tamsulosin HCL 0.2mg<br>* Tamsulosin HCL 0.2mg once a day<br>* Other names: Harmal D;|
| Experimental: Tamsulosin HCL 0.4mg<br>GL2702 GLARS-NF1 tablet (Tamsulosin HCL 0.4mg) | Drug: Tamsulosin HCL 0.4mg<br>* Tamsulosin HCL 0.4mg once a day<br>* Other names: GL2702 GLARS-NF1 Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in total International Prostate Symptom Score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in total International Prostate Symptom Score |  | 4 weeks | 
| Change from baseline to endpoint in voiding score |  | 4 weeks, 8 weeks | 
| Change from baseline to endpoint in IPSS QoL |  | 4 weeks, 8 weeks | 
| Change from baseline to endpoint in Qmax |  | 4 weeks, 8 weeks | 
| Change from baseline to endpoint in PVR |  | 4 weeks, 8 weeks | 
| Time to event/proportion of subjects with AUR |  | 8 weeks | 
| Time to event/proportion of subjects undergoing BPH related prostatic surgery |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Harnal, Lower Urinary Track Syndrome, Tamsulosin HCL 0.4mg