Estudio multicéntrico, doble ciego, controlado con placebo, de fase 3, que evalúa la seguridad y eficacia de selexipag sobre la morbimortalidad en pacientes con hipertensión arterial pulmonar

Criterios de inclusión

• Male and female patients 18-75 years old, with symptomatic PAH
• PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
• Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
• Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
• Signed informed consent
• Patients who have received prostacyclin or its analogs within 1 month before Baseline Visit, or are scheduled to receive any of these compounds during the trial
• Patients with moderate or severe obstructive lung disease
• Patients with moderate or severe restrictive lung disease
• Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
• Patients with documented left ventricular dysfunction
• Patients with severe renal insufficiency
• Patients with BMI \<18.5 Kg/m2
• Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit
• Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT
• Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training
• Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
• Life expectancy less than 12 months
• Females who are lactating or pregnant or plan to become pregnant during the study
• Known hypersensitivity to any of the excipients of the drug formulations