Clinical trial to study Macitentan for Pulmonary Artery Hypertension

Trial ID:
Thomas Heywood, M.D.
The purpose of this study is to evaluate the safety, effectiveness, and tolerability of two doses of Macitentan, 75mg vs. 10mg, to treat Pulmonary Arterial Hypertension (PAH). Study participation is expected to last 3 to 6 years.

Inclusion Criteria

Patients must:
  • 18 years or older
  • Have Symptomatic PAH in WHO FC II, III, or IV
  • Have a PAH diagnosis confirmed by hemodynamic evaluation meeting study criteria
  • Meet all other inclusion criteria

Exclusion Criteria

Patients must not:
  • Be taking prostanoid medications
  • Have a Body mass index (BMI) greater than 30 kg/m2,
  • Have Diabetes mellitus (any type),
  • Have Essential hypertension,
  • Have Coronary artery disease
  • Have moderate or severe obstructive lung disease
  • Require a lung transplant

Additional Info

  • Macitentan 10mg is currently approved by the FDA for the treatment of patients with PAH. This study will compare a higher dose of Macitentan (75mg) to the FDA approved dose.
  • Search for NCT04273945 at for more information.

Contact Info:

  • Clinical Research Services
  • 858-824-5461