deltatrials
Completed PHASE4 INTERVENTIONAL 1-arm NCT01184989

Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

An Open Label, Non-comparative, Pharmacokinetic and Pharmacodynamic Study to Evaluate the Effect of Dabigatran Etexilate on Coagulation Parameters Including a Calibrated Thrombin Time Test in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Primary Unilateral Elective Total Knee or Hip Replacement Surgery

Sponsor: Boehringer Ingelheim

Updated 7 times since 2017 Last updated: Aug 29, 2018 Started: Aug 31, 2010 Primary completion: Apr 30, 2013 Completion: Apr 30, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Arthroplasty, Replacement and Moderate Renal Impairment (CrCl 30-50 mL/Min), this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 7 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshotCompleted~Oct 2018 – ~Jan 2021 · 27 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 12 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Oct 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 2 earlier versions
  1. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE4

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Aug 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
Data source: Boehringer Ingelheim

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