Pulmonary HypertensionPhase 2NCT03122730
VentaProst Versus Conventionally-Administered Aerosolized Epoprostenol in Patients Undergoing Cardiac Surgery With CPB
A Phase 2 study testing VentaProst in people with Pulmonary Hypertension, run by Aerogen Pharma Limited at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- VentaProst
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Aug 2017to 30 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women and Men 18 to 75 years of age
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- For patients in Part I:
- Undergo cardiac surgery on CPB
- Clinically require treatment with and receive aerosolized epoprostenol
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- Demonstrate a clinically meaningful hemodynamic response to aerosolized epoprostenol
- For patients in Part II:
- Undergo cardiac surgery with CPB
- Have perioperative pulmonary hypertension
- Clinically require treatment with inhaled epoprostenol
Who cannot join
- Current smoker (i.e., within the last 30 days)
- Emergency operative status
- Upper and/or lower respiratory tract infection within four weeks of screening
- Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
- Renal or severe hepatic impairment
- Thromboembolic disease treated with anticoagulant therapy
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- Bleeding disorders
- Significant restrictive or obstructive lung disease
- History of concurrent malignancy or recurrence of malignancy within two years prior to Screening
- History of a diagnosis of drug or alcohol dependency or abuse within approximately the last three years
- Recent history of stroke or transient ischemic attack
- Significantly abnormal laboratory tests at Screening
- Pregnant or breastfeeding
- Treatment with an investigational drug, biologic, or device within 30 days
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the patient inappropriate for entry into this trial
- Any condition where aerosolized epoprostenol is contraindicated
- Known allergy or sensitivity to epoprostenol, any of its ingredients, or the diluent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tufts Medical Center
Boston, Massachusetts, 02111
Rush University Medical Center
Chicago, Illinois, 60612
Stanford University Medical Center
Stanford, California, 94305
About this study
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
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.
Read the 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
- Being tested
- VentaProst
- Keywords
- Cardiac surgery, Cardiopulmonary bypass, Epoprostenol
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentaProstCombination product
epoprostenol for inhalation via custom drug delivery system
| Study group | Role | What they receive |
|---|---|---|
| VentaProst | Experimental | VentaProst (epoprostenol solution for inhalation via custom drug delivery system)
In Part 1, subjects were treated with a commercial aerosolized epoprostenol and then removed from that treatment. VentaProst was started and titrated to a dose equivalence to maintain at least 90% of hemodynamic response seen with the commerical product.
In Part 2, subjects were treated with VentaProst only. Receives: Combination Product: VentaProst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
The primary goal was to establish the dose of VentaProst necessary to achieve a PD response comparable to the standard of care. The first dose of VentaProst tested, 17 ng/kg/min, achieved the dose equivalency.
Measured: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Secondary outcomes (1)
Optimal Dose Determination With VP Dose Escalation (Part II)
Calculate vascular resistance indicators for CI and CO, and PAPi at each dose level. Identify the VP dose where mPAP, VR(CO), VR(CI), CVP are lowest, and CI/CO are highest. Compare in a narrative to the selected VP optimal dose by the Investigator by individual patient.
Measured: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start23 Aug 2017
- Primary completion1 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerogen Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Hill, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122730
- Sponsor's protocol ID
- APC-VP-CLN-001
- Status last verified
- Jul 2025
- First submitted
- 11 Apr 2017
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03122730
- Acronym / sponsor ID
- APC-VP-CLN-001
- Conditions
- Pulmonary Hypertension
- Keywords
- Cardiac surgery, Cardiopulmonary bypass, Epoprostenol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Aerogen Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VentaProst | Experimental | Combination Product: VentaProstVentaProst (epoprostenol solution for inhalation via custom drug delivery system) In Part 1, subjects were treated with a commercial aerosolized epoprostenol and then removed from that treatment. VentaProst was started and titrated to a dose equivalence to maintain at least 90% of hemodynamic response seen with the commerical product. In Part 2, subjects were treated with VentaProst only. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women and Men 18 to 75 years of age
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
- For patients in Part I:
- For patients in Part II:
Key exclusion criteria (17 listed)
- Current smoker (i.e., within the last 30 days)
- Emergency operative status
- Upper and/or lower respiratory tract infection within four weeks of screening
- Contraindication to transesophageal echocardiogram (TEE) including esophageal disease or unstable cervical spine
- Renal or severe hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentaProstepoprostenol for inhalation via custom drug delivery system | Combination product | VentaProst |
Primary outcome
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I)
Time frame: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
The primary goal was to establish the dose of VentaProst necessary to achieve a PD response comparable to the standard of care. The first dose of VentaProst tested, 17 ng/kg/min, achieved the dose equivalency.
1 secondary outcome
Optimal Dose Determination With VP Dose Escalation (Part II)
Time frame: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Hill, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VentaProst in people with Pulmonary Hypertension, run by Aerogen Pharma Limited at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify Equivalent Dose of VentaProst Necessary to Achieve a PD Response Comparable to Standard of Care Treatment (Part I) (time frame: Pharmacodynamic changes will be measured during surgery (Day 1), post-surgery (Day 1), and from start of study treatment (Day 1) through study completion (up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.