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The objective of this study is to evaluate the efficacy and safety of KSO-0400 compared to placebo for the treatment of LUTS caused by BPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSO-0400 Low Dose | Experimental |
| |
| KSO-0400 High Dose | Experimental |
| |
| Silodosin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSO-0400 | Drug |
| ||
| KSO-0400 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in I-PSS Total Score from baseline | Baseline and 12 weeks (LOCF) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in I-PSS Sub-score from baseline | Baseline and 12 weeks (LOCF) | |
| Change in QOL Score from baseline | Baseline and 12 weeks (LOCF) | |
| Change in Qmax (maximum urinary flow rate) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katsumi Hontani | Clinical Development Dept.,Kissei Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Kanto Region | Japan |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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| Silodosin | Drug |
|
| Placebo | Drug |
|
| Baseline and 12 weeks (LOCF) |
| D052801 |
| Male Urogenital Diseases |