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Completed PHASE3 INTERVENTIONAL 2-arm NCT03153137

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects (RUBATO)

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects

Sponsor: Actelion

Conditions Congenital Heart Disease
Interventions Macitentan 10 mg Placebo
Updated 42 times since 2017 Last updated: Mar 28, 2025 Started: Aug 14, 2017 Primary completion: Jun 30, 2021 Completion: Jul 26, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03153137, this PHASE3 trial focuses on Congenital Heart Disease and remains completed. Sponsored by Actelion, it has been updated 42 times since 2017, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.

Status Flow

~Jun 2017 – ~Oct 2017 · 4 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Mar 2018 · 28 days · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Oct 2019 · 3 months · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~Jun 2020 · 2 months · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

42 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Apr 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 37 earlier versions

  1. Oct 2021 — Sep 2022 [monthly]

    Completed PHASE3

  2. Sep 2021 — Oct 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  4. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Jan 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  8. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  10. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  11. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  12. Jun 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  13. Apr 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  14. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  15. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  16. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  17. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  18. Oct 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  19. Jul 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  20. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  21. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  22. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  23. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  24. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  25. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  26. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  27. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  28. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  29. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  30. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  31. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  32. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  33. Mar 2018 — May 2018 [monthly]

    Recruiting PHASE3

  34. Feb 2018 — Mar 2018 [monthly]

    Recruiting PHASE3

  35. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE3

  36. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  37. Jun 2017 — Oct 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Actelion
Data source: Actelion

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Auckland, New Zealand , Beijing, China , Berlin, Germany , Birmingham, United Kingdom , Birmingham, United States , Boston, United States , Camperdown, Australia , Chermside, Australia , Columbus, United States and 19 more locations