A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group … (NCT04084678) | Clinical Trial Compass
TerminatedPhase 3
A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH
Stopped: Sponsor decision
United States10 participantsStarted 2021-01-20
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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.
✓. 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.