A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
NCT03626688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 687
Last updated 2026-04-14
Summary
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Conditions
- PAH
- Pulmonary Hypertension
- Pulmonary Arterial Hypertension
- Hypertension
- Connective Tissue Diseases
- Familial Primary Pulmonary Hypertension
- Vascular Diseases
- Cardiovascular Diseases
- Hypertension, Pulmonary
- Lung Diseases
- Respiratory Tract Disease
Interventions
- DRUG
-
Ralinepag
Active
- DRUG
-
Placebo
Sponsors & Collaborators
-
United Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-30
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Chile
- China
- Croatia
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Mexico
- Netherlands
- Poland
- Portugal
- Romania
- Serbia
- Singapore
- South Korea
- Spain
- Sweden
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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