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Phase : Phase III Indication : Erectile Dysfunction Study Design : open-label, fixed dose, 6-month extension study (parent study : DA8159_EDD_III)
Completer from parent study(DA8159_EDD_III)continued into a 24weeks open-label extension during which they received udenafil once daily. The study concluded with a 4-week ED treatment-free period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DA-8159 | Experimental | Udenafil(The study had one arm.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8159 (Udenafil) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety evaluation included adverse events, standard 12-lead electrocardiograms and clinical laboratory measures. The AEs measured as percentage and number of patients. | 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study) |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function(IIEF), GAQ(Global Assessment Questions), Shift to normal | The efficacy measures(Unit of Measure)
| 48 weeks(after 24 weeks of parent study), 52weeks(after 28weeks of parent study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S W Kim, MD, PhD | the Catholic University of Korea St. Mary's Hospital | Principal Investigator |
| D G Moon, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| J J Kim, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| N C Park, MD, PhD | Pusan National University Hospital | Principal Investigator |
| S W Lee, MD, PhD | Samsung Medical Center | Principal Investigator |
| J S Paick, MD, PhD | Seoul National University Hospital | Principal Investigator |
| T Y Ahn, MD, PhD | Asan Medical Center | Principal Investigator |
| K H Moon, MD, PhD | Yeungnam University Hospital | Principal Investigator |
| W S Chung, MD, PhD | Ewha Womans University Hospital | Principal Investigator |
| K S Min, MD, PhD |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| Inje University |
| Principal Investigator |
| J K Park, MD, PhD | Chonbuk National University Hospital | Principal Investigator |
| D Y Yang, MD, PhD | Kangdong Sacred Heart Hospital | Principal Investigator |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |