Sepsis Clinical Trial
Official title:
A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)
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.
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.
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