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

Pulmonary Hypertension Clinical Trial

Official title:
A Two-Part Pharmacodynamic Study to Compare VentaProst (Epoprostenol Solution for Inhalation Via Custom Drug Delivery System) Dosing to Conventionally Administered Aerosolized Epoprostenol Dosing in Cardiac Surgery Patients

Clinical Trial 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.

Clinical Trial Description

Part I:

This part of the study is designed to demonstrate the dose equivalence between off-label aerosolized epoprostenol and VentaProst using a patient's hemodynamic parameters.

Part II:

This part of the study is designed to establish a dose response relationship of VentaProst to hemodynamic effect by dose escalation in patients who have had cardiac surgery with CPB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03122730
Study type Interventional
Source Aerogen Pharma Limited
Contact
Status Completed
Phase Phase 2
Start date August 23, 2017
Completion date May 30, 2019
View Details
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