Status:
COMPLETED
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Arthroplasty, Replacement, Knee
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsul...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Inclusion criteria (selected):
- Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement
- Written Informed Consent
- Exclusion criteria
- Exclusion criteria (selected):
- Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
- Active malignant disease or current cytostatic treatment
- Known severe renal insufficiency
- Liver disease expected to have any potential impact on survival, or elevated aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2x upper limit of normal
- Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
- Pre-menopausal women who are pregnant or nursing, or are of child-bearing pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control
- Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran
- Contraindications to enoxaparin
- Participation in a clinical trial during the last 30 days
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2101 Patients enrolled
Trial Details
Trial ID
NCT00168805
Start Date
November 1 2004
Last Update
May 19 2014
Active Locations (105)
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1
1160.25.06108 Boehringer Ingelheim Investigational Site
Garren, Australian Capital Territory, Australia
2
1160.25.06106 Boehringer Ingelheim Investigational Site
Kogarah, New South Wales, Australia
3
1160.25.06110 Boehringer Ingelheim Investigational Site
Lismore, New South Wales, Australia
4
1160.25.06105 Boehringer Ingelheim Investigational Site
Bedford Park, South Australia, Australia