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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Banner University Medical Center (University of Arizona)
Tucson, Arizona, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Tampa General Hospital/University of South Florida Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Change from Baseline in peak VO2 assessed by CPET
Peak VO2 by CPET was measured at Baseline (prior to starting study drug) and Week 28
Time frame: Baseline to Week 28
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP was measured at Baseline (prior to starting study drug) and Weeks 4, 8, 12, 16, 20, 24 and 28
Time frame: Baseline to Week 28
Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope
VE/VCO2 slope (from CPET) was calculated at Baseline (prior to starting study drug) and Week 28
Time frame: Baseline to Week 28
Change from Baseline in health-related quality of life measured by the Short Form Health Survey (SF-36) Scores
SF-36 was assessed at Baseline (prior to starting study drug) and Weeks 16 and 28. The SF-36 consisted of 36 questions in 8 health categories (Vitality, Physical Functioning, Bodily Pain, General Health Perception, Role Physical, Role Emotional, Social Functioning, and Mental Health). Responses to the questions were graded on a numerical scale, with 1 as the best score and higher numbers as worse scores. The raw scores from the subscales were converted and summed by the Investigator to a total score between 0 and 100 to measure functional health and well-being from the patient's point of view. The final score range was 0 (representing the lowest possible score; worst health state) to 100 (representing the highest possible score; best health state).
Time frame: Baseline to Week 28
Time to First All-cause Non-elective Hospitalization
The time to first all-cause nonelective hospitalization during the study period will be assessed.
Time frame: Baseline to Week 28
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Hospital Britanico de Buenos Aires
Ciudad Autónoma de Bs. As., Argentina
Instituto de Cardiología de Corrientes
Corrientes, Argentina
Macquarie University
North Ryde, New South Wales, Australia
Westmead Hospital, Dept Respiratory and Sleep Medicine
Westmead, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
...and 23 more locations