Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1… (NCT04084678) | Clinical Trial Compass
TerminatedPhase 3
Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects
Stopped: Sponsor decision
United States, Argentina, Australia10 participantsStarted 2021-01-20
Plain-language summary
Study ROR-PH-302, ADVANCE CAPACITY, was 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form.
. At least 18 years of age.
. Primary diagnosis of PAH.
. Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH.
. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms
. Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 90 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening.
. Has a peak VO2 of ≥9 to \<18 mL/min/kg during the Screening CPET, as assessed by the CPET core laboratory.
Exclusion criteria
. For subjects with known human immunodeficiency virus-associated PAH, a cluster of differentiation 4 T-cell count \<200/mm3 at Screening.
. Has 3 or more left ventricular disease/dysfunction risk factors.
. Symptomatic coronary artery disease and/or myocardial infarction within past 6 months.
. Current symptomatic aortic or mitral valve disease.
. Has evidence of more than mild lung disease on pulmonary function tests performed within 1 year prior to, or during, Screening.
. Has evidence of thromboembolic disease as determined by ventilation-perfusion lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH.
. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
. Requires use of supplemental oxygen during CPET.