A Study to Evaluate Whether or Not Selexipag is Effective and Safe in Patients with Chronic Thromboembolic Pulmonary Hypertension when the Disease is Inoperable or Persistent/Recurrent After Surgery
Jacksonville, FL
The primary objective of this study is to evaluate the effect of selexipag on pulmonary vascular resistance (PVR) versus placebo in subjects with inoperable CTEPH (i.e., technically non-operable) and persistent/recurrent CTEPH after surgical (pulmonary endarterectomy [PEA]) and/or interventional (balloon pulmonary angioplasty [BPA] treatment at Week 20.
The secondary objectives are to evaluate the effects of selexipag versus placebo on exercise capacity, rate of death or hospitalizations related to Pulmonary Hypertension (PH) worsening, time to clinical worsening, WHO functional class (FC), patient reported outcomes, dyspnea, and N-terminal pro b-type natriuretic peptide (NT-proBNP).