Study Status:
Open
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
Contact:
PI: Evelyn Horn, MD
RC: Astrid Carmona, 212 746 2623