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Status:

COMPLETED

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Arthroplasty, Replacement, Knee

Venous Thrombosis

Eligibility:

All Genders

20+ years

Phase:

PHASE2

Brief Summary

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 prevent...

Eligibility Criteria

Inclusion

  • Inclusion criteria Inclusion criteria
  • Patients scheduled to undergo a primary, unilateral elective total knee replacement
  • Male or Female 20 years of age or order
  • Patients weighing at least 40 kg
  • Written informed consent prior to the start of study participation
  • Exclusion criteria Exclusion criteria
  • History of bleeding diathesis
  • Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
  • Major surgery or trauma (e.g. hip fracture) within the last 3 months
  • Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
  • Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
  • Condition requiring anti-coagulant therapy
  • Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
  • Patients with a history of clinically significant renal diseases or with elevated creatinine values

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    512 Patients enrolled

    Trial Details

    Trial ID

    NCT00246025

    Start Date

    October 1 2005

    Last Update

    June 9 2014

    Active Locations (38)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (38 locations)

    1

    1160.50.001 Boehringer Ingelheim Investigational Site

    Eniwa, Hokkaido, Japan

    2

    1160.50.018 Boehringer Ingelheim Investigational Site

    Fukuoka, Fukuoka, Japan

    3

    1160.50.008 Boehringer Ingelheim Investigational Site

    Hachioji, Tokyo, Japan

    4

    1160.50.006 Boehringer Ingelheim Investigational Site

    Hirosaki, Aomori, Japan