Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension

• Status: Completed
• Trial end date: 2021-03-29
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label extension study to determine the long-term safety and tolerability of APD811 in patients with WHO Group 1 PAH who have completed the Phase 2 study, APD811-003. Patients must have completed the APD811-003 study and must meet eligibility criteria for APD811-007.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arena Pharmaceuticals; United Therapeutics

Criteria

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document

• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures and is deemed an appropriate candidate for participation in a long-term extension study and administration of APD811

• Fulfilled all eligibility criteria for APD811-003 and completed the study as planned

• Patients who discontinued for clinical worsening in APD811-003 and were assigned to placebo and completed all end of study procedures including right heart catheterization (RHC) may participate after their data from the APD811-003 study is cleaned and locked

Exclusion Criteria:

• Patients who enrolled in APD811-003 and were withdrawn from study drug treatment due to any AE, SAE, or clinical worsening if assigned to APD811, or patients who did not complete the APD811 003 study for other reasons.

• Female patients who wish to become pregnant

• Systolic BP <90 mmHg at Baseline/Day 1

• Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study