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
GL2702 GLARS-NF1 tablet is controlled released formation which is made by GL Pharm Tech
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
309
Tamsulosin HCL 0.4mg once a day
Tamsulosin HCL 0.2mg once a day
Eulji general hospital
Seoul, South Korea
Change from baseline to endpoint in total International Prostate Symptom Score
Time frame: 8 weeks
Change from baseline to endpoint in total International Prostate Symptom Score
Time frame: 4 weeks
Change from baseline to endpoint in voiding score
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in IPSS QoL
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in Qmax
Time frame: 4 weeks, 8 weeks
Change from baseline to endpoint in PVR
Time frame: 4 weeks, 8 weeks
Time to event/proportion of subjects with AUR
Time frame: 8 weeks
Time to event/proportion of subjects undergoing BPH related prostatic surgery
Time frame: 8 weeks
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