At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
VentaProstcombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating VentaProst for Pulmonary Hypertension. Completed, enrolled 17 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartAug 2017
Primary CompletionMar 2019
Study CompletionMay 2019
TodayJul 2026
First PostedApr 21, 2017
Enrollment StartAug 23, 2017
Primary CompletionMar 1, 2019
Study CompletionMay 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.2 years ago
Interventions
VentaProstcombination
epoprostenol for inhalation via custom drug delivery system