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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01444872 | Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction | PHASE1 | COMPLETED | 17 | — | — | Aug 1, 2011 | Jun 1, 2012 | Aug 27, 2012 | 4 | United States |
| NCT01187836 | Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure | PHASE1 | COMPLETED | 33 | — | — | Dec 1, 2010 | Mar 1, 2012 | Jul 11, 2017 | 9 | United States, Czechia +1 |
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.
The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.
Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted.
| Arm | Type | Description |
|---|---|---|
| TRV120027 | EXPERIMENTAL | TRV120027 administered as an IV infusion |
| Normal Saline | PLACEBO_COMPARATOR | Normal Saline administered as an IV infusion |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TRV120027 | DRUG | IV infusion |
| Normal Saline | DRUG | IV infusion |
| Placebo | DRUG | Placebo administered for 14 hours. |
Inclusion Criteria: * Written Informed Consent * Heart Failure * Mild to moderate renal dysfunction * Age 18- \<75 * Males and females (non-childbearing potential) Exclusion Criteria: * Any significant disease or condition that would interfere with the interpretation of safety or efficacy or effi...