Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects

ROR-PH-302 was a 28-week multicenter, randomized, double-blind, placebo-controlled study. Subjects who met entry criteria were randomly allocated 2:1 to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint was change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who completed the study on study drug through Week 28 had the option to receive ralinepag in an open-label extension (OLE) study. Subjects who discontinued study drug prior to Week 28, as well as those who completed Week 28 on study drug but chose not to participate in the OLE study, were contacted every 6 months and at the end of the study to determine their survival status. Subjects who prematurely discontinued study drug or withdrew from the study for any reason were not eligible to enter the OLE study.