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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01966601 | A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure | PHASE2 | COMPLETED | 620 | — | — | Dec 1, 2013 | Sep 1, 2016 | Jul 26, 2018 | 62 | United States, Argentina +10 |
The primary clinical endpoint is a of the following outcomes: (1) time from randomization to death through day 30, (2) time from randomization to heart failure re-hospitalization through day 30, (3) time from randomization to worsening heart failure through day 5, (4) change in dyspnea VAS score (calculated area under the curve) from baseline through day 5, and (5) length of initial hospital stay (in days) from randomization. The component outcomes will be combined by deriving an average Z for each patient.
| Arm | Type | Description |
|---|---|---|
| TRV027 dose #1 | EXPERIMENTAL | TRV027 dose #1 via continuous IV infusion |
| TRV027 dose #2 | EXPERIMENTAL | TRV027 dose #2 via continuous IV infusion |
| TRV027 dose #3 | EXPERIMENTAL | TRV027 dose #3 via continuous IV infusion |
| Placebo | PLACEBO_COMPARATOR | Placebo via continuous IV infusion |
| Name | Type | Description |
|---|---|---|
| TRV027 Dose #1 | DRUG | TRV027 continuous intravenous infusion Dose #1 |
| TRV027 Dose #2 | DRUG | TRV027 continuous intravenous infusion Dose #2 |
| TRV027 Dose #3 | DRUG | TRV027 continuous intravenous infusion Dose #3 |
| Placebo | DRUG | Placebo continuous intravenous infusion |
Inclusion Criteria: 1. Men or women aged ≥21 years and ≤ 85 years 1a.Women of non-child-bearing potential 2. Able to provide written informed consent 3. Pre-existing diagnosis of heart failure and at least 30 days treatment with daily oral loop diuretics 4. Systolic blood pressure ≥105 mmHg and ≤ 1...