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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to months 12, 24, and 36 for reporting.

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

0 / 1Eligibility criteria met