A Phase 3 Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension

What Was Tested

In this phase 3 trial, researchers set out to test Angiotensin II.

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.

It had two arms (groups): LJPC-501 (angiotensin II) (experimental) and one (placebo comparator).

Treatment arm.

Placebo arm.

The registry classes the interventions as drug.

More on the Plan

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.

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).

Who Took Part

The registry lists 344 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients are required to have central venous access and an arterial line present, and these are expected to remain present for at least the initial 48 hours of study. Patients are required to have an indwelling urinary catheter present, and it is expected to remain present for at least the initial 48 hours of study. Patients must have clinical features of high-output shock by meeting one of the following criteria. Patient or legal surrogate is willing and able to provide written informed consent and comply with all protocol requirements.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: patients who are \< 18 years of age; patients with a cardiovascular (cv) sofa score ≤ 3; patients diagnosed with acute occlusive coronary syndrome requiring intervention.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Angiotensin II group and the comparison group should start out alike.

The Angiotensin II group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Angiotensin II.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-03 with completion listed for 2016-12-01.

It ran at 115 sites in United States (52), Australia (18), United Kingdom (16), Canada (10), Belgium (5) and Finland (4).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Angiotensin II in 344 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Angiotensin II compound page, all human trials.