deltatrials
Terminated PHASE3 INTERVENTIONAL 1-arm NCT01210443

Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension

Sponsor: Pfizer

Interventions Sitaxentan
Updated 9 times since 2017 Last updated: Nov 10, 2011 Started: Nov 30, 2010 Primary completion: Dec 31, 2010 Completion: Dec 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.

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This PHASE3 trial investigates Hypertension, Pulmonary and is currently terminated or withdrawn. Pfizer leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotTerminated~Aug 2017 – ~May 2018 · 9 months · monthly snapshotTerminated~May 2018 – ~Jun 2018 · 31 days · monthly snapshotTerminated~Jun 2018 – ~Nov 2020 · 29 months · monthly snapshotTerminated~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  5. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

Show 4 earlier versions
  1. Jun 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  2. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  3. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  4. Jan 2017 — Aug 2017 [monthly]

    Terminated PHASE3

    First recorded

Nov 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Pfizer
Data source: Pfizer

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