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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00443690 | Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy | PHASE3 | COMPLETED | 480 | — | — | Aug 1, 2007 | Jan 1, 2009 | Feb 20, 2009 | - | — |
| NCT00354458 | PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function | PHASE3 | COMPLETED | 1,102 | — | — | Oct 1, 2006 | Jul 1, 2009 | Oct 9, 2009 | - | — |
| NCT00328692 | PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function | PHASE3 | COMPLETED | 932 | — | — | Aug 1, 2006 | Jul 1, 2009 | Oct 9, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | placebo control |
| 1 | EXPERIMENTAL | KW-3902IV |
| Name | Type | Description |
|---|---|---|
| rolofylline | DRUG | rolofylline 30 mg IV QD; 3 days |
| Comparator: Placebo (unspecified) | DRUG | rolofylline Pbo 30 mg IV QD; 3 days |
Inclusion Criteria: * Dyspnea at rest or with minimal exertion at randomization * Fluid overload * Estimated creatinine clearance (CrCl) between 20-60 mL/min * Worsening renal function * Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug * BNP \>500 pg/mL...