Clinical trial to study Macitentan for Pulmonary Artery Hypertension
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.
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
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
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 www.clinicaltrials.gov for more information.