Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

Completed · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

This study was an open-label extension study to determine the long-term safety and tolerability of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) who have completed Study APD811-003, or who were assigned to receive placebo and were discontinued due to clinical worsening.

Key facts

Study ID

NCT02279745

Run by

United Therapeutics

People needed

45

Starts

2015-07-08

Expected to finish

2021-03-29

Last updated by the study team

2021-12-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of a personally signed and dated informed consent document.
• Was willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and was deemed an appropriate candidate for participation in a long-term extension study.
• Female subjects were nonpregnant, nonlactating, surgically sterile or postmenopausal, or agreed to use an accepted method of birth control for at least 3 months prior to the first dose, during, and for at least 30 days after the last dose of study drug.
• Male subjects were either surgically sterile or agreed to use a condom with spermicide when sexually active with a female partner who was not using an acceptable method of birth control during the study and for 30 days after the last dose of study drug.
• Male and female subjects agreed not to participate in a conception process during the study and for 30 days after the last dose of study drug.
• Fulfilled all eligibility criteria for Study APD811-003 and completed the study as planned.
• Subjects who were assigned to placebo in Study APD811-003 and experienced clinical worsening in that study could enroll in Study APD811-007 after completing all end of study procedures per protocol, including RHC, for Study APD811-003 and had their data locked.

You may not qualify if…

• Subjects who enrolled in Study APD811-003 and were withdrawn from study drug treatment due to any adverse event (AE), serious adverse event (SAE), or subjects who did not complete Study APD811003, with the exception made for placebo-treated subjects who experienced a clinical worsening event.
• Female •subjects who wished to become pregnant.
• Systolic blood pressure <90 mmHg at Baseline.
• Other severe acute or chronic medical or laboratory abnormalities that could have increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, would have made the subject inappropriate for entry into this study.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavilion — Aurora, Colorado, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Chest Medicine Associates — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Boston University Medical Center General Clinical Research Unit (GCRU) — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• UC Health — Cincinnati, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion — Columbus, Ohio, United States
• UPMC, Presbyterian — Pittsburgh, Pennsylvania, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Memorial Hermann Hospital - Texas Medical Center — Houston, Texas, United States
• St. Vincent's Hospital — Darlinghurst, New South Wales, Australia
• The Prince Charles Hospital — Chermside, Queensland, Australia
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• Fiona Stanley Hospital — Murdoch, Australia
• Multiprofile Hospital for Active Treatment "National Heart Hospital" EAD, Clinic of Cardiology — Sofia, Bulgaria
• Multiprofile Hospital for Active Treatment " St. Anna", Sofia AD, Cardiology Clinic — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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