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A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509305-68-00
Acronym
ROR-PH-303
Enrollment
156
Registered
2024-06-19
Start date
2019-05-16
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH)

Brief summary

Efficacy assessments will include an evaluation of: • NT-proBNP • 6MWD • WHO/NYHA FC • The proportion of subjects who achieve all 3 of the following (at specified time points): o NT-proBNP level <300 pg/mL o 6MWD >440 meters o WHO/NYHA FC II status or better • HRQoL measures (where validated) • Time to all-cause hospitalization during the study period • Time to all-cause mortality during the study period

Interventions

DRUGRalinepag

Sponsors

United Therapeutics Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Efficacy assessments will include an evaluation of: • NT-proBNP • 6MWD • WHO/NYHA FC • The proportion of subjects who achieve all 3 of the following (at specified time points): o NT-proBNP level <300 pg/mL o 6MWD >440 meters o WHO/NYHA FC II status or better • HRQoL measures (where validated) • Time to all-cause hospitalization during the study period • Time to all-cause mortality during the study period—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026