Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Actelion
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
