NCT03122730

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Aerogen Pharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VentaProst	epoprostenol for inhalation via custom drug delivery system

Timeline

• Start date: 2017-08-23
• Primary completion: 2019-03-01
• Completion: 2019-05-30
• First posted: 2017-04-21
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study