Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03122730
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2017-04-11
Brief Title:
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
Sponsor:
Aerogen Pharma Limited
Organization:
Aerogen Pharma Limited
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
This part of the study is designed to demonstrate the dose equivalence between off-label aerosolized epoprostenol and VentaProst using a patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None