Study Status: 
Study Description: 

Study Name: Ralinepag 301

Study Objective: A Phase 3, randomized, double-blind, placebo-controlled study to

evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background oral therapy in subjects with World

Health Organization (WHO) Group 1 pulmonary hypertension (ADVANCE Outcomes)

Key Inclusion Criteria:

  • Primary diagnosis of symptomatic PAH, IPAH, HPAH
  • WHO/NYHA FC II to IV symptoms
  • RHC w/i 3 yrs or at screening

Key Exclusion Criteria:

3 or more of following:

  •  BMI ≥30
  • DM
  • HTN
  • CAD
  • Chronic AF

2. Evidence of > mild lung disease on PFT w/i 6M

3. Evidence of thromboembolic disease

4. Severe chronic liver disease

Principal Investigator: 
Evelun Horn, MD

PI: Evelyn Horn, MD

RC: Astrid Carmona, 212 746 2623

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