Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.
Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
424
The Catholic Univ., Bucheon ST.Mary's Hospital
Bucheon-si, South Korea
Busan National Univ. Hospital
Busan, South Korea
Konkuk Univ, Chungju Hospital
Chungju, South Korea
I-PSS
Change in I-PSS total score from baseline
Time frame: 12 weeks
I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
* The rate of patients who experience a decrease in I-PSS total score of 25% or higher * The rate of patients who experience an improvement of at least 4 in I-PSS total score I-PSS * Change in Qmax from baseline * The rate of patients who experience an improvement of 30% or over in Qmax * Change in the I-PSS voiding and storage scores from baseline * Change in QoL score from baseline * Change in ICS Male Questionnaire from baseline * Patient's goal achievement score * Treatment Satisfaction Question
Time frame: 12 weeks
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Choongnam National Univ. Hospital
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...and 4 more locations