Who is sponsoring NCT00246025?

NCT00246025 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT00246025?

Interventions in NCT00246025: Dabigatran etexilate, Dabigatran etexilate, Dabigatran Etexilate, placebo.

What condition does NCT00246025 study?

NCT00246025 studies Arthroplasty, Replacement, Knee, Venous Thrombosis.

Is NCT00246025 still recruiting?

NCT00246025 is currently completed. Last updated 3 June 2014.

Are results published for NCT00246025?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-06-03 · How we verify

NCT00246025

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomised, Parallel-group, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Knee Replacement Surgery

Completed Phase 2 Results posted Last updated 3 June 2014

What this trial tests

Phase 2 trial testing Dabigatran etexilate in Arthroplasty, Replacement, Knee in 512 participants. Completed.

Timeline

1 October 2005

Primary endpoint
1 June 2007

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	512
Start date	1 October 2005
Primary completion	1 June 2007
Sites	38 locations across Japan

Drugs / interventions tested

Dabigatran etexilate (DABIGATRAN) — full drug profile →
Dabigatran etexilate (DABIGATRAN) — full drug profile →
Dabigatran Etexilate (DABIGATRAN) — full drug profile →
placebo

Conditions studied

Arthroplasty, Replacement, Knee — all drugs for Arthroplasty, Replacement, Knee →
Venous Thrombosis — all drugs for Venous Thrombosis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

20 and older, any sex, with Arthroplasty, Replacement, Knee or Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period.
Time frame: 2 weeks study medication
number of participants with the composite endpoint (total Venous Thromboembolic Event (VTE) and all cause mortality

Sponsor's own description

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Dabigatran etexilate and risk of myocardial infarction, other cardiovascular events, major bleeding, and all-cause mortality: a systematic review and meta-analysis of randomized controlled trials.
Douxfils J, Buckinx F, Mullier F, Minet V, et al · · 2014 · cited 68× · PMID 24906369 · DOI 10.1161/jaha.113.000515
Direct thrombin inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in people with non-valvular atrial fibrillation.
Salazar CA, del Aguila D, Cordova EG. · · 2014 · cited 35× · PMID 24677203 · DOI 10.1002/14651858.cd009893.pub2
Cardiovascular outcomes during treatment with dabigatran: comprehensive analysis of individual subject data by treatment.
Clemens A, Fraessdorf M, Friedman J. · · 2013 · cited 27× · PMID 24143109 · DOI 10.2147/vhrm.s49830
Efficacy and safety of anticoagulants for postoperative thrombophylaxis in total hip and knee arthroplasty: A PRISMA-compliant Bayesian network meta-analysis.
He T, Han F, Wang J, Hu Y, et al · · 2021 · cited 16× · PMID 34138850 · DOI 10.1371/journal.pone.0250096

Verify or expand the search:

Other trials of Dabigatran etexilate

Trials testing the same drug.

NCT07515339 — A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dab · Phase 1 · not yet recruiting
NCT06329895 — A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are · Phase 1 · completed
NCT05959447 — Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant · Phase 1 · completed
NCT05673889 — A Study to Understand the Effect of a Study Medicine Called ARV-471 on Dabigatran Etexilate in Healthy Adults · Phase 1 · completed
NCT05480475 — A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and R · Phase 1 · completed

Other recruiting trials for Arthroplasty, Replacement, Knee

Currently open trials in the same condition.

NCT07337772 — Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty · NA · recruiting
NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting
NCT05992064 — Wearable Sensors for Monitoring Recovery After Total Knee Arthroplasty · recruiting
NCT05518513 — Continuous Infusion and Intermittent Bolus Adductor Canal Block for Total Knee Arthroplasty · NA · recruiting
NCT04884542 — Multigen Plus H Study and AMF TT Cones · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00246025 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 3 June 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00246025.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing