UNISUS Research Study

For Healthcare Providers

Are you treating an adult who has pulmonary arterial hypertension (PAH)?

The purpose of this study is to compare Macitentan 10 mg against Macitentan 75 mg to see if it is well tolerated, safe, and useful for treating patients with pulmonary arterial hypertension (PAH). The investigational medication has been approved for other uses by the FDA at the lower dose. The primary objective is to demonstrate superiority of a higher dose of an investigational drug in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to a lower dose.

 

Please be assured that the research doctor’s involvement with your patient will be strictly study-related. If your patient decides to enroll in the study, with their permission, you can be informed of their progress in the study.

 

Key Study Inclusion Criteria:

  • At least 18 years of age
  • Symptomatic PAH in WHO FC II, III or IV
  • PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening:
    • Mean pulmonary artery pressure (mPAP) > 20 mmHg, AND
    • Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND
    • Pulmonary vascular resistance (PVR) ≥ 3 Wood Units (i.e., ≥ 240 dyn•sec•cm−5)
  • On stable background treatment for PAH or PAH treatment-naïve

 

For more information about the UNISUS Study, please visit https://clinicaltrials.gov/ct2/show/NCT04273945. You may also download a copy of the HCP flyer. This flyer is for healthcare professional use only. It is not to be shown or shared with patients.

If you have a PAH patient that may be a candidate for the UNISUS Study, you can:

Share the Study Website

Share the study website to provide education and awareness about the UNISUS Study to your patients who may qualify and be interested in the study.

Send email

Encourage Pre-Screening

Potential patients can take a short self-assessment to see if they may be eligible to participate in the UNISUS Study. If they pass the self-assessment, he/she will have the opportunity to speak with a Trialbee medical professional to ask any questions.

Download & Share the Patient Brochure

Download a copy of the patient brochure with more information about the UNISUS Study to share with your patients who may qualify and be interested in the study.

Download PDF