drugset / Trial / NCT03626688

A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

NCT03626688 ↗

Phase 3 Completed 687 enrolled United Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-01-24
Primary completion
2025-12-31
Completion
2025-12-31

Outcome

Met primary endpoint

release “The phase 3 ADVANCE OUTCOMES study of ralinepag met its primary endpoint” unither.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ralinepag Small molecule 400 ug Oral