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Prostacyclin Analogue
Treprostinil for Pulmonary Arterial Hypertension (ARTISAN Trial)
Phase 4
Recruiting
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
CardioMEMS-related Exclusion Criteria, if applicable: Previously implanted with CardioMEMS pulmonary artery Sensor or unwilling/unable to permit collection and perform upload (transmission) of pulmonary artery pressure (PAP) readings, Unable to take dual antiplatelet or anticoagulation therapy for 30 days after CardioMEMS PA Sensor implantation unless the participant has an indication for warfarin or direct oral anticoagulant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to months 12, 24, and 36
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will study the effects of a medication called treprostinil on people with pulmonary arterial hypertension. The goal is to see if the medication can lower the pressure in the arteries of the lungs and improve the function of the right ventricle of the heart.
Who is the study for?
This trial is for people with pulmonary arterial hypertension (PAH) who have a mean pulmonary artery pressure over 35 mmHg and are on stable PAH medication or willing to start it. They should be able to walk more than 165 meters, not have severe liver issues, and can't be using certain other medications or have conditions that affect heart imaging tests.
What is being tested?
The study is testing the effectiveness of Treprostinil therapy administered early and rapidly in two forms—parenteral (injected) and oral—to lower high blood pressure in the lungs' arteries, improve heart function on the right side, and reverse changes due to PAH.
What are the potential side effects?
Treprostinil may cause side effects like headaches, diarrhea, nausea, rash, jaw pain when eating, muscle or bone pain. It might also lead to flushing or reddening of the skin.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a CardioMEMS sensor implanted and can take blood thinners for 30 days post-implant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to months 12, 24, and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to months 12, 24, and 36
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants With Clinical Improvement From Baseline to Month 12, 24, and 36
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreprostinilExperimental Treatment2 Interventions
Participants will receive parenteral treprostinil at initial dose of 1.25 nanograms/kilogram/minute (at minimum) either intravenously or subcutaneously. Based on mPAP assessments and after a minimum dose of parenteral treprostinil is reached, at Investigator's (PI's) discretion, participants may transition to oral treprostinil and continue dose uptitration for further reduction of mPAP. Based on Month 12 mPAP assessment, participants may transition from parenteral to oral treprostinil at PI's discretion after completion of Month 12 assessment and continue uptitration for further reduction of mPAP. If minimum dose of parenteral treprostinil is not reached at Month 6/12 at PI's discretion, uptitration of parenteral treprostinil or oral treprostinil transition may occur to maintain normal mPAP.
Treprostinil therapy (parenteral or oral) may continue as tolerated toward goal of further reduction of mPAP until Month 36.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Treprostinil
2007
Completed Phase 3
~900
Find a Location
Who is running the clinical trial?
Lung Biotechnology PBCIndustry Sponsor
13 Previous Clinical Trials
661 Total Patients Enrolled
9 Trials studying Pulmonary Arterial Hypertension
533 Patients Enrolled for Pulmonary Arterial Hypertension
United TherapeuticsLead Sponsor
110 Previous Clinical Trials
14,476 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
8,235 Patients Enrolled for Pulmonary Arterial Hypertension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Before joining the study, your heart catheterization must meet certain measurements, and you must be on specific medications for your condition.Criterion Summary: You will be excluded from the study if you have used specific medications, have certain types of pulmonary hypertension, have used certain drugs within the past year, have certain medical conditions, have used other investigational treatments recently, or have certain cardiac conditions or implants that could interfere with the study.My PAH is related to genetics, drugs (not amphetamines), heart repair, connective tissue disease, or HIV.I have not had a CardioMEMS sensor implanted and can take blood thinners for 30 days post-implant.
Research Study Groups:
This trial has the following groups:- Group 1: Treprostinil
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pulmonary Arterial Hypertension Patient Testimony for trial: Trial Name: NCT05203510 — Phase 4