Clinical Trial Description

The ARTISAN clinical trial is a phase 4, multicenter, single-arm study. This means that the study drug has already been approved by the US FDA for treatment of pulmonary arterial hypertension (PAH), and investigators are gathering additional information about the drug’s effectiveness when it is administered earlier and with faster increase in dose. In single-arm clinical trials, the study drug is not compared to another drug or placebo (inactive drug). This means that every patient participant enrolled in the trial is given the study drug.

About the Clinical Trial

CLINICAL TRIAL DESIGN

The ARTISAN clinical trial subject participation is expected to last approximately 37 months (3 years). Eligible participants who enroll in the clinical trial will participate in three phases of the study, which will include one 30-day screening period, one 12-month treatment period during which study doctors will evaluate the specific goals of the clinical trial, and one 24-month extended treatment period.

Confident senior woman looking thoughtful outdoors
Happy mother and daughter having tender moment together

CLINICAL TRIAL PURPOSE

The purpose of the ARTISAN clinical trial is to determine whether administering treprostinil (study drug) early and quickly increasing the dose can improve PAH. The clinical trial will assess if there are improvements to include reducing PAH symptoms, improving the function of the right ventricle (a chamber of the heart), and reversing changes in the size and shape of the right ventricle due to PAH.

Eligibility Criteria

In order to be eligible for this clinical trial, the participant must provide informed consent and meet the following inclusion and exclusion criteria*:

  • Be aged 18 years or older.
  • Have a confirmed diagnosis of PAH.
  • Be treatment naïve (have never undergone treatment for PAH) or on a stable dose of a study-approved treatment for PAH for at least 30 days, but less than six months, prior to the baseline visit.
  • Be either male or female.
  • Be able to walk at least 165 meters (541 feet) during a six-minute walk test.
  • Meet the required parameters during the Right Heart Catheterization (RHC) procedure performed as part of eligibility determination.

Study Drug

Treprostinil is a form of a chemical compound called prostacyclin. Parenteral (non-oral) treprostinil, Remodulin® (treprostinil) Injection, is approved to diminish symptoms associated with exercise, and oral treprostinil, Orenitram® (treprostinil) Extended-release Tablets, is approved to delay disease progression and to improve exercise ability in patients with PAH. In this study, both parenteral and oral treprostinil are considered the study drug and will be administered under the supervision of your study doctor. The clinical trial will evaluate whether the study drug could potentially improve additional symptoms of PAH.

Helpful Information for Subjects About Remodulin

Think You May Qualify?

Visit clinicaltrials.gov/ct2/show/NCT05203510 to learn more and for contact information.