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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02338843 | A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension | PHASE3 | COMPLETED | 344 | — | — | Mar 1, 2015 | Feb 18, 2017 | Mar 27, 2018 | 115 | United States, Australia +8 |
Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.
| Arm | Type | Description |
|---|---|---|
| LJPC-501 (angiotensin II) | EXPERIMENTAL | Treatment arm |
| Placebo (0.9% sodium chloride solution) | PLACEBO_COMPARATOR | Placebo arm |
| Name | Type | Description |
|---|---|---|
| LJPC-501 | DRUG | Treatment arm |
| Placebo | DRUG | PBO |
Inclusion Criteria: 1. Adult patients ≥ 18 years of age with CRH, defined as those who require a total sum catecholamine dose of \> 0.2 mcg/kg/min for a minimum of 6 hours and a maximum of 48 hours, to maintain a MAP between 55-70 mmHg. 2. Patients are required to have central venous access and an ...