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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00168805
Registration number
NCT00168805
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
19/05/2014
Titles & IDs
Public title
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
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Scientific title
RE-MODEL (Thromboembolism Prevention After Knee Surgery). Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With a Half Dose (i.e.75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 6-10 Days
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Secondary ID [1]
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2004-001317-34
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Secondary ID [2]
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1160.25
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee
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Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - enoxaparin
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - dabigatran etexilate
Experimental: dabigatran etexilate 220 mg - 220 mg once daily
Experimental: dabigatran etexilate 150 mg - 150 mg once daily
Active comparator: enoxaparin - 40 mg once daily
Treatment: Drugs: enoxaparin
40 mg once daily
Treatment: Drugs: dabigatran etexilate
150 mg once daily
Treatment: Drugs: dabigatran etexilate
220 mg once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
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Assessment method [1]
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Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
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Timepoint [1]
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First administration until 6-10 days
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Secondary outcome [1]
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Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
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Assessment method [1]
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Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
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Timepoint [1]
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First administration until 6-10 days
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Secondary outcome [2]
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Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
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Assessment method [2]
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Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [2]
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First administration until 6-10 days
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Secondary outcome [3]
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Number of Participants With Total Deep Vein Thrombosis During Treatment Period
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Assessment method [3]
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Total Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [3]
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First administration until 6-10 days
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Secondary outcome [4]
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Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
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Assessment method [4]
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Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
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Timepoint [4]
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First administration until 6-10 days
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Secondary outcome [5]
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Number of Participants With Pulmonary Embolism During Treatment Period
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Assessment method [5]
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Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
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Timepoint [5]
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First administration until 6-10 days
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Secondary outcome [6]
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Number of Participants Who Died During Treatment Period
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Assessment method [6]
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All cause death, as adjudicated by the VTE events committee
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Timepoint [6]
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First administration until 6-10 days
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Secondary outcome [7]
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Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
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Assessment method [7]
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Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
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Timepoint [7]
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3 months
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Secondary outcome [8]
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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
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Assessment method [8]
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Major bleeding events were defined as
* fatal
* clinically overt associated with loss of haemoglobin \>=20g/L in excess of what was expected
* clinically overt leading to the transfusion of \>=2 units packed cells or whole blood in excess of what was expected
* symptomatic retroperitoneal, intracranial, intraocular or intraspinal
* requiring treatment cessation
* leading to re-operation
Clinically-relevant was defined as
* spontaneous skin hematoma greater than or equal to 25 cm²
* wound hematoma greater than or equal to 100 cm²
* spontaneous nose bleed lasting longer than 5 min
* macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
* spontaneous rectal bleeding (more than a spot on toilet paper)
* gingival bleeding lasting longer than 5 min
* any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
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Timepoint [8]
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First administration until 6-10 days
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Secondary outcome [9]
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Blood Transfusion
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Assessment method [9]
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Blood transfusion for treated and operated patients on Day of surgery.
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Timepoint [9]
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Day 1
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Secondary outcome [10]
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Volume of Blood Loss
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Assessment method [10]
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Volume of blood loss for treated and operated patients during surgery.
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Timepoint [10]
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Day 1
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Secondary outcome [11]
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Laboratory Analyses
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Assessment method [11]
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Frequency of patients with possible clinically significant abnormalities.
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Timepoint [11]
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First administration to end of study
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Eligibility
Key inclusion criteria
Inclusion criteria
Inclusion criteria (selected):
* Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee replacement
* Written Informed Consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
2101
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
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Recruitment hospital [1]
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1160.25.06108 Boehringer Ingelheim Investigational Site - Garren
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Recruitment hospital [2]
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1160.25.06106 Boehringer Ingelheim Investigational Site - Kogarah
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Recruitment hospital [3]
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1160.25.06110 Boehringer Ingelheim Investigational Site - Lismore
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Recruitment hospital [4]
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1160.25.06105 Boehringer Ingelheim Investigational Site - Bedford Park
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Recruitment hospital [5]
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1160.25.06107 Boehringer Ingelheim Investigational Site - Toorak Gardens
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Recruitment hospital [6]
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1160.25.06109 Boehringer Ingelheim Investigational Site - Woodville
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Recruitment hospital [7]
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1160.25.06104 Boehringer Ingelheim Investigational Site - Box Hill
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Recruitment hospital [8]
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1160.25.06102 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [9]
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1160.25.06101 Boehringer Ingelheim Investigational Site - Malvern
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Recruitment hospital [10]
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1160.25.06103 Boehringer Ingelheim Investigational Site - Ringwood East
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Recruitment hospital [11]
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1160.25.06113 Boehringer Ingelheim Investigational Site - Windsor
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Recruitment hospital [12]
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1160.25.06111 Boehringer Ingelheim Investigational Site - Perth
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Recruitment postcode(s) [1]
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- Garren
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Recruitment postcode(s) [2]
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- Kogarah
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Recruitment postcode(s) [3]
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- Lismore
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Recruitment postcode(s) [4]
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- Bedford Park
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Recruitment postcode(s) [5]
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- Toorak Gardens
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Recruitment postcode(s) [6]
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- Woodville
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Recruitment postcode(s) [7]
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- Box Hill
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Recruitment postcode(s) [8]
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- Clayton
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Recruitment postcode(s) [9]
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- Malvern
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Recruitment postcode(s) [10]
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- Ringwood East
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Recruitment postcode(s) [11]
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- Windsor
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Recruitment postcode(s) [12]
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- Perth
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Recruitment outside Australia
Country [1]
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Austria
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Linz
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Austria
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Wels
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Austria
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Wien
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Austria
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Wr. Neustadt
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Belgium
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Brussels
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Herentals
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Belgium
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Lanaken
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Belgium
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Leuven
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Brno-Bohunice
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Chomutov
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Havlickuv Brod
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Kladno
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Silkeborg
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Seinäjoki
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France
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Soyaux
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France
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St Etienne cedex 2
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France
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Strasbourg cedex 2
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Germany
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Bad Mergentheim
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Wiesbaden
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Budapest
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Békéscsaba
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Gyula
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Parma
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Italy
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Pavia
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Italy
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Reggio Emilia
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Italy
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Treviso
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Netherlands
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Amsterdam
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Nijmegen
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Sittard
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Zwolle
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Poland
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Kielce
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Krakow
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Warsaw
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South Africa
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Bryanston
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South Africa
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Randburg
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South Africa
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Sandton
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Spain
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Alcorcón (Madrid)
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Spain
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Barcelona
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Spain
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Hospitalet (Barcelona)
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Spain
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Jaén
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Spain
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Madrid
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Spain
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Móstoles (Madrid)
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Valencia
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Falköping
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Göteborg
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Halmstad
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Kungälv
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Lidköping
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Linköping
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Mölndal
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Sweden
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Stockholm
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Sweden
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Varberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)
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Trial website
https://clinicaltrials.gov/study/NCT00168805
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Trial related presentations / publications
Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17. Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00168805
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