drugset / Trial / NCT03623529

A Study of LJPC-501 in Paediatric Patients With Hypotension Associated With Distributive or Vasodilatory Shock

NCT03623529

Phase 2 Unknown 100 enrolled La Jolla Pharmaceutical Company
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate the effect of LJPC-501 infusion on mean arterial pressure (MAP) as assessed by standard of care vasopressor dose reduction in pediatric patients with catecholamine-resistant hypotension (CRH). In addition, this study will evaluate the safety and tolerability of LJPC-501 in pediatric patients, evaluate changes in catecholamine and other vasopressor doses over time, evaluate the change in MAP over time, and the change in Pediatric Logistic Organ Dysfunction-2 (PELOD-2) scores.

Timeline

Start
2018-08
Primary completion
2023-03
Completion
2023-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Angiotensin II Peptide