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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00709865 | Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency | PHASE3 | COMPLETED | 420 | — | — | Jul 31, 2008 | Dec 31, 2009 | Sep 11, 2023 | 189 | United States, Argentina +16 |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | .03 mg/kg |
| 2 | EXPERIMENTAL | .15 mg/kg |
| 3 | EXPERIMENTAL | .3 mg/kg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| tonapofylline | DRUG | IV |
| Placebo | DRUG | IV |
Inclusion Criteria: * Previous diagnosis of heart failure. * Must have ADHF, requiring hospitalization, with clinical evidence for volume overload Exclusion Criteria: * History of an allergic reaction to any xanthine-containing substance. * History of seizure * History of stroke * Myocardial infa...