Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRV027 Dose #1 · 1 trial · 1 indication
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...
TRV027 Dose #1 is an investigational small molecule being studied for the treatment of Acute Decompensated Heart Failure. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being developed by Trevena, Inc. for patients hospitalized with this condition.
TRV027 Dose #1 is being developed by Trevena, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol TRVN. The company is conducting clinical research to evaluate the drug's efficacy in patients with Acute Decompensated Heart Failure.
TRV027 Dose #1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of Acute Decompensated Heart Failure, and its clinical trial has been completed.
TRV027 Dose #1 has one completed Phase 2 clinical trial registered under NCT01966601, titled 'A Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure.' The trial enrolled 620 participants and was conducted in multiple countries including the United States, Argentina, Bulgaria, Canada, and others.
TRV027 Dose #1 is a specific dose of the investigational drug TRV027. The clinical trial NCT01966601 evaluates TRV027 in patients with Acute Decompensated Heart Failure. Trevena, Inc. is developing this drug, and it is currently in Phase 2 development.