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

NCT03122730 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-07-31

Study results available
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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.

Conditions

  • Pulmonary Hypertension

Interventions

COMBINATION_PRODUCT

VentaProst

epoprostenol for inhalation via custom drug delivery system

Sponsors & Collaborators

  • Aerogen Pharma Limited

    lead INDUSTRY

Principal Investigators

  • Charles Hill, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2019-03-01
Completion
2019-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03122730 on ClinicalTrials.gov