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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00808067
Registration number
NCT00808067
Ethics application status
Date submitted
12/12/2008
Date registered
15/12/2008
Date last updated
9/06/2014
Titles & IDs
Public title
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
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Scientific title
RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes
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Secondary ID [1]
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0
2008-005248-17
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Secondary ID [2]
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0
1160.71
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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:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - dabigatran dose 1
Treatment: Drugs - dabigatran dose 2
Experimental: dabigatran dose 1 - dabigatran high dose twice daily
Experimental: dabigatran dose 2 - dabigatran low dose twice daily
Treatment: Drugs: dabigatran dose 1
dabigatran high dose twice daily
Treatment: Drugs: dabigatran dose 2
dabigatran low dose twice 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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Major Bleeding, Annualized Rate of Subjects With Major Bleeds
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Assessment method [1]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Major bleeding must have satisfied one or more of the following criteria:
Bleeding associated with a reduction in hemoglobin of at least 20 g/L
Required transfusion of at least 2 units of blood or packed cells
Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal
Major bleed were classified as life-threatening if they met one or more of the following criteria:
Reduction in hemoglobin of at least 50 g/L
Transfusion of at least 4 units of blood or packed cells
Symptomatic intracranial bleeding, either subdural or intracerebral
Associated with hypotension requiring use of intravenous inotropic agents
Required surgical intervention to stop bleeding
Resulted in death
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Timepoint [1]
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up to 43 months
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Secondary outcome [1]
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Stroke, Annualized Rate of Subjects With Stroke
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Assessment method [1]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
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Timepoint [1]
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up to 43 months
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Secondary outcome [2]
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Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
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Assessment method [2]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
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Timepoint [2]
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up to 43 months
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Secondary outcome [3]
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Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
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Assessment method [3]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Pulmonary Embolism was generally documented by one of the following:
an intraluminal filling defect in segmental or more proximal branches on spiral CT scan
an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
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Timepoint [3]
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up to 43 months
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Secondary outcome [4]
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Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
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Assessment method [4]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
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Timepoint [4]
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up to 43 months
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Secondary outcome [5]
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Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
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Assessment method [5]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deep Vein Thrombosis (DVT) was generally documented by one of the following:
abnormal compression ultrasound (CUS),
an intraluminal filling defect on venography.
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Timepoint [5]
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up to 43 months
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Secondary outcome [6]
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Death, Annualized Rate of Subject Death
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Assessment method [6]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
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Timepoint [6]
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up to 43 months
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Secondary outcome [7]
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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
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Assessment method [7]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [7]
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up to 43 months
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Secondary outcome [8]
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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
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Assessment method [8]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [8]
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up to 43 months
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Secondary outcome [9]
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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
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Assessment method [9]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [9]
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up to 43 months
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Secondary outcome [10]
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Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
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Assessment method [10]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [10]
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up to 43 months
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Secondary outcome [11]
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Annualized Rate of Subjects With Minor Bleeds
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Assessment method [11]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
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Timepoint [11]
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up to 43 months
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Secondary outcome [12]
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Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
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Assessment method [12]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [12]
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up to 43 months
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Secondary outcome [13]
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Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
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Assessment method [13]
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Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
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Timepoint [13]
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up to 43 months
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Eligibility
Key inclusion criteria
Inclusion criteria:
Participation in RE-LY, requires long term anticoagulation, provides 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:
Permanent discontinuation of dabigatran during RE-LY
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Study design
Purpose of the study
Treatment
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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
1/11/2008
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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
1/12/2012
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Sample size
Target
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Accrual to date
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Final
5897
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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1160.71.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
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Recruitment hospital [2]
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1160.71.0510 Boehringer Ingelheim Investigational Site - Gosford
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Recruitment hospital [3]
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1160.71.0506 Boehringer Ingelheim Investigational Site - Milton
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Recruitment hospital [4]
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1160.71.0509 Boehringer Ingelheim Investigational Site - Ashford
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Recruitment hospital [5]
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1160.71.0507 Boehringer Ingelheim Investigational Site - Launceston
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Recruitment hospital [6]
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1160.71.0504 Boehringer Ingelheim Investigational Site - Box Hill
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Recruitment hospital [7]
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1160.71.0501 Boehringer Ingelheim Investigational Site - Geelong
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Recruitment postcode(s) [1]
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- Coffs Harbour
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Recruitment postcode(s) [2]
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- Gosford
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Recruitment postcode(s) [3]
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- Milton
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Recruitment postcode(s) [4]
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- Ashford
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Recruitment postcode(s) [5]
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- Launceston
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Recruitment postcode(s) [6]
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- Box Hill
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Recruitment postcode(s) [7]
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- Geelong
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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State/province [2]
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Arizona
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United States of America
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State/province [3]
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Arkansas
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United States of America
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State/province [4]
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California
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Country [5]
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United States of America
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State/province [5]
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Colorado
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Country [6]
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United States of America
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State/province [6]
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Connecticut
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Country [7]
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United States of America
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State/province [7]
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Florida
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Country [8]
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United States of America
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State/province [8]
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Georgia
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Country [9]
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United States of America
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State/province [9]
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Illinois
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Country [10]
0
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United States of America
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State/province [10]
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Indiana
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Country [11]
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United States of America
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State/province [11]
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Iowa
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Country [12]
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United States of America
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State/province [12]
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Kentucky
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United States of America
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State/province [13]
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Louisiana
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State/province [14]
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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Nevada
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Washington
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West Virginia
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Wisconsin
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Country [39]
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Austria
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Graz
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Austria
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Linz
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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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Aalst
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Belgium
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Brasschaat
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Belgium
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Brussel
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Belgium
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Bruxelles
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Belgium
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Edegem
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Belgium
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Genk
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Belgium
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Belgium
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Belgium
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Oostende
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Belgium
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Roeselare
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Belgium
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Tienen
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Belgium
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Turnhout
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Goiania
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Brazil
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Brazil
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São José do Rio Preto
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Brazil
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São Paulo
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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Nova Scotia
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0
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Canada
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Ontario
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Canada
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Quebec
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Canada
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0
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Saskatchewan
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0
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China
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Beijing
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China
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Haerbin
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China
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Hangzhou
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China
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QingDao
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China
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Shanghai
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China
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Shenyang
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China
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Shijiazhuang
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Czech Republic
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Modrice
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Czech Republic
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Ostrava 1
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Czech Republic
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Pardubice
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Czech Republic
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Plzen-Bory
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Czech Republic
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Praha 5
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Czech Republic
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Czech Republic
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Praha 9
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Czech Republic
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Pribram
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Czech Republic
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Usti nad Orlici
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Denmark
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Aalborg
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Denmark
Query!
State/province [90]
0
0
Aarhus C
Query!
Country [91]
0
0
Denmark
Query!
State/province [91]
0
0
Frederikssund
Query!
Country [92]
0
0
Denmark
Query!
State/province [92]
0
0
Helsingør
Query!
Country [93]
0
0
Denmark
Query!
State/province [93]
0
0
Herlev
Query!
Country [94]
0
0
Denmark
Query!
State/province [94]
0
0
Horsens
Query!
Country [95]
0
0
Denmark
Query!
State/province [95]
0
0
Hvidovre
Query!
Country [96]
0
0
Denmark
Query!
State/province [96]
0
0
Køge
Query!
Country [97]
0
0
Denmark
Query!
State/province [97]
0
0
Odense
Query!
Country [98]
0
0
Denmark
Query!
State/province [98]
0
0
Roskilde
Query!
Country [99]
0
0
Denmark
Query!
State/province [99]
0
0
Svendborg
Query!
Country [100]
0
0
Finland
Query!
State/province [100]
0
0
Helsinki
Query!
Country [101]
0
0
Finland
Query!
State/province [101]
0
0
Jyväskylä
Query!
Country [102]
0
0
Finland
Query!
State/province [102]
0
0
Oulu
Query!
Country [103]
0
0
Finland
Query!
State/province [103]
0
0
Pori
Query!
Country [104]
0
0
Finland
Query!
State/province [104]
0
0
Tampere
Query!
Country [105]
0
0
Finland
Query!
State/province [105]
0
0
Turku
Query!
Country [106]
0
0
France
Query!
State/province [106]
0
0
ABBEVILLE cedex
Query!
Country [107]
0
0
France
Query!
State/province [107]
0
0
Angers
Query!
Country [108]
0
0
France
Query!
State/province [108]
0
0
Besle Sur Vilaine
Query!
Country [109]
0
0
France
Query!
State/province [109]
0
0
Cholet
Query!
Country [110]
0
0
France
Query!
State/province [110]
0
0
Château Gontier
Query!
Country [111]
0
0
France
Query!
State/province [111]
0
0
Derval
Query!
Country [112]
0
0
France
Query!
State/province [112]
0
0
Feneu
Query!
Country [113]
0
0
France
Query!
State/province [113]
0
0
GRENOBLE Cédex 9
Query!
Country [114]
0
0
France
Query!
State/province [114]
0
0
La Chapelle sur Erdre
Query!
Country [115]
0
0
France
Query!
State/province [115]
0
0
Langres
Query!
Country [116]
0
0
France
Query!
State/province [116]
0
0
Laval
Query!
Country [117]
0
0
France
Query!
State/province [117]
0
0
Le Mesnil en Valée
Query!
Country [118]
0
0
France
Query!
State/province [118]
0
0
Murs Erigne
Query!
Country [119]
0
0
France
Query!
State/province [119]
0
0
Nantes
Query!
Country [120]
0
0
France
Query!
State/province [120]
0
0
Parcay les Pins
Query!
Country [121]
0
0
France
Query!
State/province [121]
0
0
Paris
Query!
Country [122]
0
0
France
Query!
State/province [122]
0
0
Saint Aubin Des Chateaux
Query!
Country [123]
0
0
France
Query!
State/province [123]
0
0
Segre
Query!
Country [124]
0
0
France
Query!
State/province [124]
0
0
Tierce
Query!
Country [125]
0
0
France
Query!
State/province [125]
0
0
Vieillevigne
Query!
Country [126]
0
0
France
Query!
State/province [126]
0
0
Vihiers
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Berlin
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
Bochum
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Dortmund
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Essen
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Frankfurt am Main
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Heidelberg
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Köln
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Lahr
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Limburg
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Mainz
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Mannheim
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Witten
Query!
Country [139]
0
0
Germany
Query!
State/province [139]
0
0
Wuppertal
Query!
Country [140]
0
0
Greece
Query!
State/province [140]
0
0
Athens
Query!
Country [141]
0
0
Greece
Query!
State/province [141]
0
0
Kalamaria-Thessaloniki
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Larissa
Query!
Country [143]
0
0
Greece
Query!
State/province [143]
0
0
Thiva
Query!
Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Trikala
Query!
Country [145]
0
0
Greece
Query!
State/province [145]
0
0
Voula - Athens
Query!
Country [146]
0
0
Hong Kong
Query!
State/province [146]
0
0
Kowloon
Query!
Country [147]
0
0
Hungary
Query!
State/province [147]
0
0
Budapest
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Gyongyos
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Komarom
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Pecs
Query!
Country [151]
0
0
India
Query!
State/province [151]
0
0
Ahmedabad-52
Query!
Country [152]
0
0
India
Query!
State/province [152]
0
0
Ahmedabad
Query!
Country [153]
0
0
India
Query!
State/province [153]
0
0
Bangalore
Query!
Country [154]
0
0
India
Query!
State/province [154]
0
0
Hyderabad
Query!
Country [155]
0
0
India
Query!
State/province [155]
0
0
Jaipur, Rajasthan
Query!
Country [156]
0
0
India
Query!
State/province [156]
0
0
Kerala
Query!
Country [157]
0
0
India
Query!
State/province [157]
0
0
Kottayam
Query!
Country [158]
0
0
India
Query!
State/province [158]
0
0
Lucknow, Uttar Pradesh
Query!
Country [159]
0
0
India
Query!
State/province [159]
0
0
Ludhiana
Query!
Country [160]
0
0
India
Query!
State/province [160]
0
0
Mysore
Query!
Country [161]
0
0
India
Query!
State/province [161]
0
0
Nagpur-12
Query!
Country [162]
0
0
India
Query!
State/province [162]
0
0
New Delhi
Query!
Country [163]
0
0
India
Query!
State/province [163]
0
0
Pune, Maharashtra
Query!
Country [164]
0
0
Israel
Query!
State/province [164]
0
0
Afula
Query!
Country [165]
0
0
Israel
Query!
State/province [165]
0
0
Ashkelon
Query!
Country [166]
0
0
Israel
Query!
State/province [166]
0
0
Givatayim
Query!
Country [167]
0
0
Israel
Query!
State/province [167]
0
0
Hadera
Query!
Country [168]
0
0
Israel
Query!
State/province [168]
0
0
Haifa
Query!
Country [169]
0
0
Israel
Query!
State/province [169]
0
0
Holon
Query!
Country [170]
0
0
Israel
Query!
State/province [170]
0
0
Jerusalem
Query!
Country [171]
0
0
Israel
Query!
State/province [171]
0
0
Kfar Saba
Query!
Country [172]
0
0
Israel
Query!
State/province [172]
0
0
Petah Tikva
Query!
Country [173]
0
0
Israel
Query!
State/province [173]
0
0
Ramat Gan
Query!
Country [174]
0
0
Israel
Query!
State/province [174]
0
0
Rehovot
Query!
Country [175]
0
0
Israel
Query!
State/province [175]
0
0
Safed
Query!
Country [176]
0
0
Israel
Query!
State/province [176]
0
0
Tel Aviv
Query!
Country [177]
0
0
Israel
Query!
State/province [177]
0
0
Tel-Aviv
Query!
Country [178]
0
0
Italy
Query!
State/province [178]
0
0
Arezzo
Query!
Country [179]
0
0
Italy
Query!
State/province [179]
0
0
Ascoli Piceno
Query!
Country [180]
0
0
Italy
Query!
State/province [180]
0
0
Sassari
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Busan
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Cheonan-si
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Daegu
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Gwangju
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Incheon
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Seoul
Query!
Country [187]
0
0
Malaysia
Query!
State/province [187]
0
0
Kuala Lumpur
Query!
Country [188]
0
0
Netherlands
Query!
State/province [188]
0
0
's Hertogenbosch
Query!
Country [189]
0
0
Netherlands
Query!
State/province [189]
0
0
Almelo
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Amsterdam
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Apeldoorn
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
Breda
Query!
Country [193]
0
0
Netherlands
Query!
State/province [193]
0
0
Den Helder
Query!
Country [194]
0
0
Netherlands
Query!
State/province [194]
0
0
Deventer
Query!
Country [195]
0
0
Netherlands
Query!
State/province [195]
0
0
Dirksland
Query!
Country [196]
0
0
Netherlands
Query!
State/province [196]
0
0
Ede
Query!
Country [197]
0
0
Netherlands
Query!
State/province [197]
0
0
Eindhoven
Query!
Country [198]
0
0
Netherlands
Query!
State/province [198]
0
0
Enschede
Query!
Country [199]
0
0
Netherlands
Query!
State/province [199]
0
0
Goes
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Gorinchem
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Groningen
Query!
Country [202]
0
0
Netherlands
Query!
State/province [202]
0
0
Heerlen
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Hengelo
Query!
Country [204]
0
0
Netherlands
Query!
State/province [204]
0
0
Hilversum
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Hoorn
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Maastricht
Query!
Country [207]
0
0
Netherlands
Query!
State/province [207]
0
0
Meppel
Query!
Country [208]
0
0
Netherlands
Query!
State/province [208]
0
0
Rotterdam
Query!
Country [209]
0
0
Netherlands
Query!
State/province [209]
0
0
Sneek
Query!
Country [210]
0
0
Netherlands
Query!
State/province [210]
0
0
Tiel
Query!
Country [211]
0
0
Netherlands
Query!
State/province [211]
0
0
Tilburg
Query!
Country [212]
0
0
Netherlands
Query!
State/province [212]
0
0
Veldhoven
Query!
Country [213]
0
0
Netherlands
Query!
State/province [213]
0
0
Velp
Query!
Country [214]
0
0
Netherlands
Query!
State/province [214]
0
0
Zwijndrecht
Query!
Country [215]
0
0
Norway
Query!
State/province [215]
0
0
Gjøvik
Query!
Country [216]
0
0
Norway
Query!
State/province [216]
0
0
Moss
Query!
Country [217]
0
0
Norway
Query!
State/province [217]
0
0
Nordbyhagen
Query!
Country [218]
0
0
Norway
Query!
State/province [218]
0
0
Oslo
Query!
Country [219]
0
0
Norway
Query!
State/province [219]
0
0
RUD
Query!
Country [220]
0
0
Philippines
Query!
State/province [220]
0
0
Ermita Manila
Query!
Country [221]
0
0
Philippines
Query!
State/province [221]
0
0
Manila
Query!
Country [222]
0
0
Philippines
Query!
State/province [222]
0
0
Pasig City
Query!
Country [223]
0
0
Philippines
Query!
State/province [223]
0
0
Quezon City
Query!
Country [224]
0
0
Poland
Query!
State/province [224]
0
0
Gdynia
Query!
Country [225]
0
0
Poland
Query!
State/province [225]
0
0
Pulawy
Query!
Country [226]
0
0
Poland
Query!
State/province [226]
0
0
Warsaw
Query!
Country [227]
0
0
Poland
Query!
State/province [227]
0
0
Zabrze
Query!
Country [228]
0
0
Portugal
Query!
State/province [228]
0
0
Amadora
Query!
Country [229]
0
0
Portugal
Query!
State/province [229]
0
0
Carnaxide
Query!
Country [230]
0
0
Portugal
Query!
State/province [230]
0
0
Coimbra
Query!
Country [231]
0
0
Portugal
Query!
State/province [231]
0
0
Covilhã
Query!
Country [232]
0
0
Portugal
Query!
State/province [232]
0
0
Porto
Query!
Country [233]
0
0
Romania
Query!
State/province [233]
0
0
Bucharest
Query!
Country [234]
0
0
Russian Federation
Query!
State/province [234]
0
0
Moscow
Query!
Country [235]
0
0
Russian Federation
Query!
State/province [235]
0
0
St. Petersburg
Query!
Country [236]
0
0
Singapore
Query!
State/province [236]
0
0
Singapore
Query!
Country [237]
0
0
Slovakia
Query!
State/province [237]
0
0
Banska Bystrica
Query!
Country [238]
0
0
Slovakia
Query!
State/province [238]
0
0
Bratislava
Query!
Country [239]
0
0
Slovakia
Query!
State/province [239]
0
0
Kosice
Query!
Country [240]
0
0
Slovakia
Query!
State/province [240]
0
0
Zilina
Query!
Country [241]
0
0
Sweden
Query!
State/province [241]
0
0
Göteborg
Query!
Country [242]
0
0
Sweden
Query!
State/province [242]
0
0
Malmö
Query!
Country [243]
0
0
Sweden
Query!
State/province [243]
0
0
Norrköping
Query!
Country [244]
0
0
Sweden
Query!
State/province [244]
0
0
Nässjö
Query!
Country [245]
0
0
Sweden
Query!
State/province [245]
0
0
Stockholm
Query!
Country [246]
0
0
Sweden
Query!
State/province [246]
0
0
Umeå
Query!
Country [247]
0
0
Sweden
Query!
State/province [247]
0
0
Uppsala
Query!
Country [248]
0
0
Sweden
Query!
State/province [248]
0
0
Västerås
Query!
Country [249]
0
0
Sweden
Query!
State/province [249]
0
0
Örebro
Query!
Country [250]
0
0
Switzerland
Query!
State/province [250]
0
0
Basel
Query!
Country [251]
0
0
Switzerland
Query!
State/province [251]
0
0
Bellinzona
Query!
Country [252]
0
0
Switzerland
Query!
State/province [252]
0
0
Bern
Query!
Country [253]
0
0
Switzerland
Query!
State/province [253]
0
0
Lugano
Query!
Country [254]
0
0
Taiwan
Query!
State/province [254]
0
0
Changhua
Query!
Country [255]
0
0
Taiwan
Query!
State/province [255]
0
0
Hualien
Query!
Country [256]
0
0
Taiwan
Query!
State/province [256]
0
0
Kaohsiung
Query!
Country [257]
0
0
Taiwan
Query!
State/province [257]
0
0
Taichung
Query!
Country [258]
0
0
Taiwan
Query!
State/province [258]
0
0
Tainan
Query!
Country [259]
0
0
Taiwan
Query!
State/province [259]
0
0
Taipei
Query!
Country [260]
0
0
Taiwan
Query!
State/province [260]
0
0
Taoyuan
Query!
Country [261]
0
0
Thailand
Query!
State/province [261]
0
0
Bangkok
Query!
Country [262]
0
0
Thailand
Query!
State/province [262]
0
0
Chiang Mai
Query!
Country [263]
0
0
Thailand
Query!
State/province [263]
0
0
Khon Kaen
Query!
Country [264]
0
0
United Kingdom
Query!
State/province [264]
0
0
Birmingham
Query!
Country [265]
0
0
United Kingdom
Query!
State/province [265]
0
0
Chertsey
Query!
Country [266]
0
0
United Kingdom
Query!
State/province [266]
0
0
County Armagh
Query!
Country [267]
0
0
United Kingdom
Query!
State/province [267]
0
0
Kirkcaldy, Fife
Query!
Country [268]
0
0
United Kingdom
Query!
State/province [268]
0
0
London
Query!
Country [269]
0
0
United Kingdom
Query!
State/province [269]
0
0
Newcastle upon Tyne
Query!
Country [270]
0
0
United Kingdom
Query!
State/province [270]
0
0
Newport
Query!
Country [271]
0
0
United Kingdom
Query!
State/province [271]
0
0
Northampton
Query!
Country [272]
0
0
United Kingdom
Query!
State/province [272]
0
0
Romford, Essex
Query!
Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
York
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
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Summary
Brief summary
The purposes of this study are:
1. To evaluate the long-term safety of dabigatran etexilate
2. To assess the effect of a knowledge translation intervention on patient outcomes
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00808067
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Principal investigator
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Boehringer Ingelheim
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Boehringer Ingelheim
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00808067
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