Research Study: A DUE
Condition:
pulmonary arterial hypertension (PAH)
Study Sponsor: Actelion
Study Investigator: Barry Cabuay, MD
Study Contact: Sarah Schwager
sarah.schwager@allina.com
612-863-6257
Every research study comes with its own unique risks and benefits; the study team will assess whether you’re an eligible candidate and ensure you’re provided with all the information you need to decide if participating is right for you.
About this Study:

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective that therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
Eligibility Criteria:

  • Signed and dated informed consent form (ICF)
  • Confirmed diagnosis of symptomatic PAH in WHO FC II or III
  • Symptomatic PAH belonging to one of the following subgroups of WHO Group 1 pulmonary hypertension:
    • Idiopathic
    • Heritable
    • Drug- or toxin-induced
    • Associated with connective tissue disease, HIV infection, portal hypertension or congenital heart disease with simple systemic-to-pulmonary shunt with persistent pulmonary hypertension documented by a right heart catheterization (RHC) ≥ 1 year after surgical repair
  • PAH diagnosis confirmed by hemodynamic evaluation at rest (through central reading), evaluated within 5 weeks prior to randomization:
    • Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, AND
    • Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, AND
    • Pulmonary vascular resistance (PVR) ≥ 3 WU (i.e., ≥ 240 dyn∙sec∙cm−5)
  • Negative vasoreactivity test in idiopathic, heritable, and drug/toxin-induced PAH
  • Neither no history of PAH-specific treatment or currently receiving a stable dose of ERA or PDE-5i monotherapy for at least 3 months prior to baseline RHC, within the specified doses in the study protocol
  • Subject able to perform the 6MWT with a minimum distance of 100 m and maximum distance of 450 m at Screening
  • A woman of childbearing potential must:
    • have negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization
    • agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study treatment discontinuation
    • agree to follow the contraception scheme from Screening up to at least 30 days after study treatment discontinuation

Interested in participating in this study?

Reach out to the study contact directly, or fill out this form and we will contact you and assess whether you are an eligible candidate!