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Riociguat in Children With Pulmonary Arterial Hypertension (PAH)

Study acronym: PATENT-CHILD
StatusActive, Not Recruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 120 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Aug 3, 2027 to May 15, 2028 Site details revised at 6 of 16 sites Show 1 more changeShow less
    • Site details revised at 6 of 16 sites
  2. Site details revised at 1 of 16 sitesv119
  3. Re-verified, no change to tracked fieldsv118
  4. Study sites revised (16)v117 See this version in full on ClinicalTrials.gov ↗
  5. 2 versions Re-verified since Feb 6, 2026, no change to tracked fieldsv115-v116
Show 44 earlier versionsHide 44 earlier versions
  1. Site details revised at 1 of 16 sitesv114
  2. 3 versions Re-verified since Sep 1, 2025, no change to tracked fieldsv111-v113
  3. Completion date: Jul 31, 2026 to Aug 3, 2027v110
  4. 2 versions Re-verified since May 5, 2025, no change to tracked fieldsv108-v109
  5. Study sites revised (16)v107 See this version in full on ClinicalTrials.gov ↗
  6. 5 versions Re-verified since Nov 13, 2024, no change to tracked fieldsv102-v106
  7. Study sites revised (16)v101 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv100
  9. Completion date: Jan 27, 2031 to Jul 31, 2026v99
  10. Site details revised at 4 of 16 sitesv98
  11. 6 versions Re-verified since Jan 3, 2024, no change to tracked fieldsv92-v97
  12. Study sites revised (16)v91 See this version in full on ClinicalTrials.gov ↗
  13. Re-verified, no change to tracked fieldsv90
  14. Study sites revised (16)v89 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (16)v88 See this version in full on ClinicalTrials.gov ↗
  16. 4 versions Re-verified since Apr 17, 2023, no change to tracked fieldsv84-v87
  17. Site details revised at 1 of 16 sitesv83
  18. Re-verified, no change to tracked fieldsv82
  19. Site details revised at 1 of 16 sitesv81
  20. 2 versions Re-verified since Nov 7, 2022, no change to tracked fieldsv79-v80
  21. Study sites revised (16)v78 See this version in full on ClinicalTrials.gov ↗
  22. 2 versions Re-verified since Aug 15, 2022, no change to tracked fieldsv76-v77
  23. Study Status, Contacts/Locationsv75
  24. Completion date: Nov 25, 2031 to Jan 27, 2031v74
  25. 3 versions Re-verified since Feb 8, 2022, no change to tracked fieldsv71-v73
  • 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.
Bayer
131 trials monitored
See 7 trials at risk
Hypertension
1,795 trials monitored
See 85 trials at risk
This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study design consisted of a main study part followed by an optional long-term extension part. The main treatment period consisted of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.
Trial Details
NCT Number NCT02562235
Lead Sponsor Bayer
Collaborators: Merck Sharp & Dohme LLC
Conditions Hypertension, Pulmonary
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov