Last updated on August 2020

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients


Brief description of study

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Detailed Study Description

Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study (after the target number of events is achieved) will have the option to enroll in an open-label extension (OLE) study.

Clinical Study Identifier: NCT03626688

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Central Florida Pulmonary

Orlando, FL United States
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Santa Barbara Cottage Hospital

Santa Barbara, CA United States
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University of Miami

Miami, FL United States
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Cleveland Clinic Florida

Weston, FL United States
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Emory University Hospital

Atlanta, GA United States
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University of New Mexico

Albuquerque, NM United States
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NYU Langone Medical Center

New York, NY United States
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The Oregon Clinic

Portland, OR United States
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NewSTAT, PLLC

Knoxville, TN United States
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University of Virginia Medical Center

Charlottesville, VA United States
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Fundacion Favaloro

Ciudad Autonoma Buenos Aires, Argentina
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St. Vincent Medical Group, Inc.

Indianapolis, IN United States
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Hospital Italiano

Ciudad Autonoma Buenos Aires, Argentina
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Nepean Hospital

Sydney, Australia
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Ochsner Medical Center

New Orleans, LA United States
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University of Rochester

Rochester, NY United States
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Temple University

Philadelphia, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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National Jewish Health

Denver, CO United States
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Winthrop Hospital

Mineola, NY United States
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University of Pennsylvania

Philadelphia, PA United States
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The Alfred Hospital

Melbourne, Australia
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Samsung Medical Center

Seoul, Korea, Republic of
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University of Arizona

Tucson, AZ United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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Chest Medicine Associates

South Portland, ME United States
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Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina
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Fundacion Respirar

Ciudad Autonoma Buenos Aires, Argentina
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University of Florida

Gainesville, FL United States
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Keck Hospital of USC

Los Angeles, CA United States
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East Carolina University

Greenville, NC United States
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Integris Baptist Medical Center

Oklahoma City, OK United States
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UCSD Health Sciences

La Jolla, CA United States
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Recruitment Status: Open


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