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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00668005 | Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension | PHASE3 | COMPLETED | 388 | — | — | Feb 1, 2003 | Sep 1, 2003 | Dec 16, 2014 | - | — |
| NCT00658177 | Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction | PHASE3 | COMPLETED | 463 | — | — | Jun 1, 2003 | Feb 1, 2004 | Dec 2, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456) | DRUG | 5mg, 10mg or 20mg taken 1h before sexual intercourse |
| Placebo | DRUG | Matching placebo |
Inclusion Criteria: * Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, * Arterial hypertension adequately controlled * Stable sexual relationship for \> 6 month Exclusion Criteria: * Primary hypoactive sexual desire * History of myocardial i...