drugset / Trial / NCT03122730

VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB

NCT03122730

Phase 2 Completed 17 enrolled Aerogen Pharma Limited
NaSingle-groupOpen-labelTreatment

Summary

The purpose of the Phase 2a study is to: 1) demonstrate that the estimated VentaProst dose is safe and equivalent in effect to a dose administered via epoprostenol aerosolization by the current off-label-use practice; and 2) demonstrate that an optimum effect can be rapidly obtained with VentaProst titration.

Timeline

Start
2017-08-23
Primary completion
2019-03-01
Completion
2019-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject epoprostenol Other / unclassified Inhaled