Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01774864 | Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction | PHASE3 | COMPLETED | 349 | — | — | Apr 1, 2011 | May 1, 2012 | Jan 24, 2013 | - | — |
| Arm | Type | Description |
|---|---|---|
| DA-8159 dose 1 | EXPERIMENTAL | Udenafil |
| DA-8159 dose 2 | EXPERIMENTAL | Udenafil |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DA-8159 (Udenafil) | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Male patients aged 20 years or more diagnosed with ED Exclusion Criteria: * Had uncontrolled blood pressure * Had hepatic or renal dysfunction * Was currently under anticancer chemotherapy * Had a treatments for ED using other PDE-5 inhibitors