Study ROR-PH-302, ADVANCE CAPACITY, is designed to evaluate the effects of ralinepag therapy
on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from
cardiopulmonary exercise testing (CPET) after 28 weeks of treatment
ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study.
Subjects who meet entry criteria will be randomly allocated 2:1 to receive ralinepag or
placebo, in addition to their PAH-specific background therapy, as applicable. The primary
endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who
complete the study on study drug through Week 28 will have the option to receive ralinepag in
an open-label extension (OLE) study. Subjects who discontinue study drug prior to Week 28, as
well as those who complete Week 28 on study drug but choose not to participate in the OLE
study, will be contacted every 6 months and at the end of the study to determine their
survival status. Subjects who prematurely discontinue study drug or withdraw from the study
for any reason will not be eligible to enter the OLE study.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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