NCT04084678

A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

ROR-PH-302 is a 28-week multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 2:1 to receive ralinepag or placebo, in addition to their PAH-specific background therapy, as applicable. The primary endpoint is change from Baseline in peak VO2 (assessed by CPET) at Week 28. All subjects who complete the study on study drug through Week 28 will have the option to receive ralinepag in an open-label extension (OLE) study. Subjects who discontinue study drug prior to Week 28, as well as those who complete Week 28 on study drug but choose not to participate in the OLE study, will be contacted every 6 months and at the end of the study to determine their survival status. Subjects who prematurely discontinue study drug or withdraw from the study for any reason will not be eligible to enter the OLE study.

Conditions

• PAH
• Pulmonary Hypertension
• Hypertension
• Connective Tissue Disease
• Familial Primary Pulmonary Hypertension
• Vascular Diseases
• Cardiovascular Diseases
• Hypertension, Pulmonary
• Lung Diseases
• Respiratory Tract Disease
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Ralinepag	Oral ralinepag
DRUG	Placebo	Matching oral tablets

Timeline

• Start date: 2021-01-20
• Primary completion: 2023-04-12
• Completion: 2023-04-12
• First posted: 2019-09-10
• Last updated: 2023-10-24

Locations

33 sites across 12 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study