Completed PHASE3 INTERVENTIONAL 3-arm NCT00152971

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

A Phase III, Randomized, Parallel-group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens (75mg Day 1 Followed by 150 mg Day 2-completion, and 110 mg Day 1 Followed by 220 mg Day 2-completion) of Dabigatran Etexilate Administered Orally (Capsules), Compared to Enoxaparin 30 mg Twice a Day Subcutaneous for 12 - 15 Days in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

Sponsor: Boehringer Ingelheim

Conditions Arthroplasty, Replacement, Knee Thromboembolism

Interventions Dabigatran Dose 1 - day 1 Dabigatran Dose 1 - day 2 to completion Dabigatran Dose 2 - day 1 Dabigatran Dose 2 - day 2 to completion Enoxaparin

Updated 6 times since 2017 Last updated: Apr 22, 2014 Started: Nov 30, 2004 Primary completion: Jun 30, 2006

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Arthroplasty, Replacement, Knee and Thromboembolism, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 6 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Nov 2004

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 .

Study Locations

Ajax, Canada , Alexandria, United States , Atlanta, United States , Aurora, United States , Austin, United States , Baltimore, United States , Barrie, Canada , Bay Pines, United States , Bend, United States , Birmingham, United States and 71 more locations