Study Status:
Open
Study Description:
Study Name: Ralinepag 303
Study Objective: A Phase 3 open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) (ADVANCE Extension)
Key Inclusion Criteria:
- Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.
Key Exclusion Criteria:
- Subjects who withdrew consent during participation in another ralinepag study.
- Subjects who have undergone lung or heart/lung transplant or the initiation of long-term
- Parenteral (IV or SC infusion) or inhaled therapy with a prostacyclin or oral
- therapy with another IP receptor agonist during the time since participation in their
- original ralinepag study.
- Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
Principal Investigator:
Evelun Horn, MD
Contact:
PI: Evelyn Horn, MD
RC: Astrid Carmona, 212 746 2623