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A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 95 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 24 of 190 sites
  2. 2 versions Re-verified since Jan 16, 2026, no change to tracked fieldsv93-v94
  3. Study sites: 209 to 190v92
  4. Re-verified, no change to tracked fieldsv91
  5. Study sites revised (209)v90 See this version in full on ClinicalTrials.gov ↗
Show 44 earlier versionsHide 44 earlier versions
  1. Primary and study completion dates: Sep 2024 to Dec 2026 Site details revised at 20 of 209 sitesv89 Show 1 more changeShow less
    • Site details revised at 20 of 209 sites
  2. Study sites: 208 to 209v88
  3. Re-verified, no change to tracked fieldsv87
  4. Study sites: 209 to 208v86
  5. Study sites: 208 to 209v85
  6. Re-verified, no change to tracked fieldsv84
  7. Study sites: 207 to 208v83
  8. 2 versions Re-verified since Feb 23, 2024, no change to tracked fieldsv81-v82
  9. Study sites revised (207)v80 See this version in full on ClinicalTrials.gov ↗
  10. Re-verified, no change to tracked fieldsv79
  11. Study sites: 196 to 207v78
  12. Study sites: 195 to 196v77
  13. Study sites: 194 to 195v76
  14. Study sites: 193 to 194v75
  15. Study sites: 192 to 193v74
  16. Study sites: 198 to 192v73
  17. Re-verified, no change to tracked fieldsv72
  18. Study sites: 202 to 198v71
  19. Study sites: 201 to 202v70
  20. Study sites: 200 to 201v69
  21. Study sites: 199 to 200v68
  22. Study sites: 194 to 199v67
  23. Study sites: 193 to 194v66
  24. Study sites: 192 to 193v65
  25. Study sites: 191 to 192v64
  26. Study sites: 190 to 191v63
  27. Study sites: 189 to 190v62
  28. Study sites: 188 to 189v61
  29. Study sites: 187 to 188v60
  30. Study sites: 186 to 187v59
  31. Study sites: 185 to 186v58
  32. Re-verified, no change to tracked fieldsv57
  33. Study sites: 183 to 185v56
  34. Study sites: 182 to 183v55
  35. Study sites: 180 to 182v54
  36. Study sites: 179 to 180v53
  37. Re-verified, no change to tracked fieldsv52
  38. Study sites: 178 to 179v51
  39. Study sites: 177 to 178v50
  40. Re-verified, no change to tracked fieldsv49
  41. Study sites: 175 to 177v48
  42. Study sites: 174 to 175v47
  43. Study sites: 169 to 174v46
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
United Therapeutics
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Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
Trial Details
NCT Number NCT03683186
Lead Sponsor United Therapeutics
Conditions PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases +3 more
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov