Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSD
Dates
study started
completion around
Principal Investigator
by Adam J. Brownstein, MD (ucla)
Headshot of Adam J. Brownstein
Adam J. Brownstein

Description

Summary

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.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH

Details

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 who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.

Keywords

PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease, Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function, Respiratory Tract Diseases, Ralinepag

Eligibility

Locations

Lead Scientist at University of California Health

  • Adam J. Brownstein, MD (ucla)
    Hs Clinical Instructor, Medicine. Authored (or co-authored) 31 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT03626688
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1000 study participants
Last Updated