Clinical Trials

Inclusion Criteria:

• Target population: ≥ 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age.
• Target population:
  • Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV.
• Target population:
  • PAH subtype falling in one of the below classifications:
    • Idiopathic; Heritable;
    • Drug- or toxin-induced.
  • Related to:
    • Connective tissue disease;
    • HIV infection;
    • Portal hypertension;
    • Congenital heart disease with simple systemic-to-pulmonary shunt (atrial septal defect, ventricular septal defect, patent ductus arteriosus) with persistent PH documented by an Right heart catheterization (RHC) ≥ 1 year after surgical repair.
• PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening:
  • Mean pulmonary artery pressure (mPAP) > 20 millimeters of mercury (mmHg), and;
  • Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg, and PVR ≥ 3 Wood Units (that is, ≥ 240 dyn*sec/cm^5).
• Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters and maximum distance of 440 meters at screening.

Exclusion Criteria:

• Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history:
  • Body mass index (BMI) > 30 kilograms per meter square (kg/m^2;
  • Diabetes mellitus of any type;
  • Essential hypertension (even if well controlled).
  • Coronary artery disease, that is, any of the following:
    • history of stable angina, or known more than 50 percent (%) stenosis in a coronary artery; or
    • history of myocardial infarction; or
    • history of or planned coronary artery bypass grafting and/or coronary artery stenting.
• Known presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after bronchodilator administration) at any time prior to screening.
• Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history.
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 1.5 * upper limit of normal (ULN) at screening.
• Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening.