Conditions: Catecholamine-resistant Hypotension (CRH) Distributive Shock High Output Shock Sepsis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 344
Healthy volunteers: no

Brief summary:
This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

Detailed description:
Catecholamine-resistant hypotension (CRH) is an often fatal condition resulting from an underlying cause such as septic shock, inflammation due to trauma, or severe drug reactions. When these conditions occur, most patients will respond to either volume expansion or vasopressor treatment. However, some patients will require excessive doses of vasopressors and will be deemed to be resistant.

Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of patients with catecholamine-resistant hypotension (CRH).

This is a multi-site, randomized, double-blind, placebo-controlled study. Adult patients with CRH, who are hospitalized in an ICU setting, may be eligible to participate. Approximately 315 patients will be enrolled.

Arms:
arm 1: Treatment arm arm 2: Placebo arm

Interventions: intervention 1: LJPC-501 intervention 2: Placebo
Intervention descriptions: intervention 1: Treatment arm intervention 2: PBO

Protocol document: