deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT01229254

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter

A Phase II, Open-label, Dose Exposure Confirmation Study to Evaluate the Pharmacokinetics and Safety and Tolerability of Betrixaban (MK-4448) in Adult Patients With Nonvalvular Atrial Fibrillation or Atrial Flutter

Sponsor: Portola Pharmaceuticals

Conditions Atrial Fibrillation Atrial Flutter
Interventions Amiodarone Betrixaban 30 mg Betrixaban 60 mg Betrixaban 90 mg
Updated 10 times since 2017 Last updated: Aug 3, 2023 Started: Sep 30, 2010 Primary completion: Dec 31, 2010 Completion: Apr 30, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Atrial Fibrillation and Atrial Flutter, this trial is completed. The trial is conducted by Portola Pharmaceuticals and has accumulated 10 data snapshots since 2010. Cardiovascular trials of this type often inform treatment guidelines for long-term patient management.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Aug 2017 · 6 months · monthly snapshotCompleted~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshotCompleted~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2023 · 32 months · monthly snapshotCompleted~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshotCompleted~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 23 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Dec 2023 — Jul 2024 [monthly]

    Completed PHASE2

  4. Sep 2023 — Dec 2023 [monthly]

    Completed PHASE2

  5. Jan 2021 — Sep 2023 [monthly]

    Completed PHASE2

▶ Show 5 earlier versions

  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  2. Oct 2017 — Jun 2018 [monthly]

    Completed PHASE2

  3. Aug 2017 — Oct 2017 [monthly]

    Completed PHASE2

  4. Feb 2017 — Aug 2017 [monthly]

    Completed PHASE2

  5. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Sep 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Portola Pharmaceuticals
Data source: Alexion Pharmaceuticals, Inc.

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

Study Locations

No location information available.