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Status:

COMPLETED

BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Venous Thromboembolism

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaq...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Patients scheduled to undergo a primary elective total hip or knee replacement.
  • Male of female being 18 years or older.
  • Patients weighing at least 40 kg.
  • Written informed consent for study participation.
  • Exclusion criteria
  • Bleeding diathesis, constitutional or acquired coagulation disorders.
  • Major surgery or trauma(e.g., hip fracture) within the last 3 months.
  • Cardiovascular disease
  • Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
  • Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
  • History of or acute intracranial disease
  • Liver disease
  • Renal disease
  • Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
  • Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
  • Known allergy to contrast media
  • Thrombocytopenia
  • Allergy against heparin.
  • Active malignant disease or current cytostatic treatment.
  • Treatment with an investigational drug in the past month.
  • Leg amputee
  • Known alcohol or drug abuse

Exclusion

    Key Trial Info

    Start Date :

    November 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    1973 Patients enrolled

    Trial Details

    Trial ID

    NCT01225822

    Start Date

    November 1 2002

    Last Update

    May 19 2014

    Active Locations (59)

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

    Page 1 of 15 (59 locations)

    1

    1160.19.43004 Krankenhaus der Barmherzigen Schwestern Linz

    Linz, Austria

    2

    1160.19.43002 Orthopädisches Spital Speising

    Vienna, Austria

    3

    1160.19.43001 A.ö. Krankenhaus d. Statutarstadt Wiener Neustadt

    Wiener Neustadt, Austria

    4

    1160.19.32002 V.U.B. Jette

    Brussels, Belgium