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This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.
The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.
Design:
Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naftopidil dose 2 | Experimental | PO administration |
|
| Placebo | Placebo Comparator | PO administration | |
| Naftopidil dose 1 | Experimental | PO administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naftopidil | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy(IPSS score change) | From 0 week(baseline) to 12 week(end of the treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy(IPSS, Uroflowmetry parameter, LUTS-GAQ) | From 0 week(baseline) to 12 week(end of the treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sae-Woong Kim, MD.PhD | Seoul St. Mary's Hospital | Principal Investigator |
| Jae-Seok Hyun, Md, PhD | Gyeongsang National University Hospital | Principal Investigator |
| Du-Geon Moon, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Nam-Cheol Park, MD, PhD | Pusan National University Hospital | Principal Investigator |
| Sung-Won Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| Soo-Woong Kim, Md, PhD | Seoul National University Hospital | Principal Investigator |
| Tai-Young Ahn, Md, PhD | Asan Medical Center | Principal Investigator |
| Ki-Hak Moon, Md, PhD | Yeongnam University Hospital | Principal Investigator |
| Woo-Sik Chung, MD,PhD | Ewha Womans University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam national university hospital | Gwangju | South Korea |
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| Kweon-Sik Min, MD, PhD |
| Inje University |
| Principal Investigator |
| Jong Kwan Park, MD, PhD | Chonbuk National University Hospital | Principal Investigator |
| Dae Yul Yang Yang, MD, PhD | Kangdong Sacred Heart Hospital | Principal Investigator |
| Ji- Kan Ryu, MD, PhD | Inha University Hospital | Principal Investigator |
| ID | Term |
|---|---|
| C064357 | naftopidil |
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