ADVANCE OUTCOMES: A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in Pulmonary Arterial Hypertension Patients
About
This is a randomized, double-blind, placebo-controlled study that is event-driven; the study could last approximately 15 to 48 months.
This study includes a screening period, titration period and optimal-dosing period to investigate the effects of ralinepag treatment outcomes on patients with pulmonary arterial hypertension (PAH). Subjects who meet entry criteria will be randomly allocated a 1:1 ratio to receive ralinepag or placebo in addition to their standard of care or PAH-specific background oral therapy.
All subjects who complete the study will have an option to receive ralinepag in an open-label extension study.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Primary diagnosis of symptomatic PAH
- Has had a right heart catheterization (PHC) performed at or within 3 years
- 6-minute walk distance ≥150 meters
- No changes in medications within 30 days of first visit
Exclusion Criteria
- Evidence of more than mild lung disease on pulmonary function tests
- Current diagnosis of ongoing and clinically significant sleep apnea
- Prior participation in any study of ralinepag
Primary Investigator
Dr. Sameh Aziz is an assistant professor at the Virginia Tech Carilion School of Medicine. He is a Pulmonary and Critical Care Medicine and Sleep Medicine specialist for Carilion Clinic. He is board certified by the American Board of Internal Medicine as well as the American Board of Sleep Medicine and the American board of Echocardiography. Dr. Aziz completed his internship and residency at the University of Virginia, Roanoke-Salem program.
Contact Information
Haley Blaisure, B.S
Clinical Research Coordinator
