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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00329238
Registration number
NCT00329238
Ethics application status
Date submitted
23/05/2006
Date registered
24/05/2006
Date last updated
19/05/2014
Titles & IDs
Public title
Secondary Prevention of Venous Thrombo Embolism (VTE).
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Scientific title
A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
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Secondary ID [1]
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2005-002536-94
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Secondary ID [2]
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1160.47
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Universal Trial Number (UTN)
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Trial acronym
RE-MEDY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thromboembolism
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
0
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 - Dabigatran
Treatment: Drugs - Warfarin
Experimental: Dabigatran - Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Active comparator: Warfarin (INR of 2.0-3.0) - Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Treatment: Drugs: Dabigatran
Dabigatran 150 mg BID (twice daily)
Treatment: Drugs: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0
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Intervention code [1]
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0
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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Composite of Recurrent VTE or VTE Death at 36 Months
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Assessment method [1]
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Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
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Timepoint [1]
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36 months
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Primary outcome [2]
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Composite of Recurrent VTE or VTE Death at 18 Months
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Assessment method [2]
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Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.
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Timepoint [2]
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18 months
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Secondary outcome [1]
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Composite of Recurrent VTE or All Cause Death at 36 Months
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Assessment method [1]
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Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
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Timepoint [1]
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0
36 months
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Secondary outcome [2]
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0
Composite of Recurrent VTE or All Cause Death at 18 Months
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Assessment method [2]
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Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation.
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Timepoint [2]
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18 months
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Secondary outcome [3]
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Deep Vein Thrombosis (DVT) at 36 Months
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Assessment method [3]
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Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
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Timepoint [3]
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36 months
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Secondary outcome [4]
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DVT at 18 Months
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Assessment method [4]
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Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.
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Timepoint [4]
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18 months
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Secondary outcome [5]
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Symptomatic Pulmonary Embolism (PE) at 36 Months
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Assessment method [5]
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Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
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Timepoint [5]
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36 months
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Secondary outcome [6]
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Symptomatic Pulmonary Embolism (PE) at 18 Months
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Assessment method [6]
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Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.
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Timepoint [6]
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0
18 months
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Secondary outcome [7]
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0
Deaths Related to VTE at 36 Months
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Assessment method [7]
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Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
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Timepoint [7]
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0
36 months
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Secondary outcome [8]
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0
Deaths Related to VTE at 18 Months
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Assessment method [8]
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Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.
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Timepoint [8]
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0
18 months
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Secondary outcome [9]
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Deaths of All Causes at 36 Months
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Assessment method [9]
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Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
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Timepoint [9]
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0
36 months
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Secondary outcome [10]
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0
Deaths of All Causes at 18 Months
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Assessment method [10]
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Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.
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Timepoint [10]
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18 months
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Secondary outcome [11]
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Number of Participants With Bleeding Events
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Assessment method [11]
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MBE (major bleeding event) if it fulfilled at least one of the following criteria
* Fatal bleeding
* Symptomatic bleeding in a critical area or organ.
* Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs
CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria
* Spontaneous skin haematoma =25 cm2
* Spontaneous nose bleed \>5 min duration
* Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting \>24 h
* Spontaneous rectal bleeding
* Gingival bleeding \>5 min
* Bleeding leading to hospitalisation or requiring surgical treatment
* Bleeding leading to a transfusion of \<2 units of whole blood or red cells
* Any other bleeding event considered clinically relevant by the investigator
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Timepoint [11]
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0
first intake of study drug until 6 days following last intake of study drug
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Secondary outcome [12]
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Laboratory Analysis
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Assessment method [12]
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Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: =3 x ULN (AST, ALT), =2 x ULN (AP), and =2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).
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Timepoint [12]
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18 months + 30 days follow up
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Secondary outcome [13]
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Number of Participants With Definite Acute Coronary Syndrome (ACS)
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Assessment method [13]
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All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.
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Timepoint [13]
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day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
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Eligibility
Key inclusion criteria
Inclusion criteria:
Inclusion_Criteria
* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing
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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
* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
* Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
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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
1/05/2006
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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
2867
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
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Recruitment hospital [1]
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0
1160.47.61002 Princess Alexandra Hospital - Wooloongabba
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Recruitment hospital [2]
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1160.47.61004 Boehringer Ingelheim Investigational Site - Bedford Park
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Recruitment hospital [3]
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1160.47.61003 Boehringer Ingelheim Investigational Site - Box Hill
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Recruitment hospital [4]
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1160.47.61001 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [5]
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1160.47.61006 Boehringer Ingelheim Investigational Site - Windsor
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Recruitment hospital [6]
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1160.47.61005 Boehringer Ingelheim Investigational Site - Perth
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Recruitment postcode(s) [1]
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- Wooloongabba
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Recruitment postcode(s) [2]
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- Bedford Park
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Recruitment postcode(s) [3]
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- Box Hill
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Windsor
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Recruitment postcode(s) [6]
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- Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Connecticut
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
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Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
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Maryland
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
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State/province [7]
0
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Michigan
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Country [8]
0
0
United States of America
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State/province [8]
0
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Minnesota
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Hampshire
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New Mexico
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Country [11]
0
0
United States of America
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State/province [11]
0
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North Carolina
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Country [12]
0
0
United States of America
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State/province [12]
0
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North Dakota
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Country [13]
0
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United States of America
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State/province [13]
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Ohio
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Country [14]
0
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United States of America
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State/province [14]
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Pennsylvania
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Country [15]
0
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United States of America
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State/province [15]
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South Carolina
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Country [16]
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United States of America
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State/province [16]
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Virginia
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Country [17]
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Argentina
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State/province [17]
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Adrogué
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Country [18]
0
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Argentina
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State/province [18]
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Bahía Blanca
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Country [19]
0
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Argentina
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State/province [19]
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Capital Federal
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Country [20]
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Argentina
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State/province [20]
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La Plata
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Country [21]
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Argentina
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State/province [21]
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Mar del Plata
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Country [22]
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Argentina
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State/province [22]
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Quilmes
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Country [23]
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Argentina
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State/province [23]
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Rosario
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Country [24]
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Argentina
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State/province [24]
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Salta
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Country [25]
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Argentina
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State/province [25]
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Santa Fe
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Country [26]
0
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Austria
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State/province [26]
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Graz
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Country [27]
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Austria
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Innsbruck
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Austria
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Wien
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Country [29]
0
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Brasília
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Brazil
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State/province [33]
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Campinas - SP
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Country [34]
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Brazil
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Curitiba
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Brazil
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Juvene - Paraná -
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Country [36]
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Brazil
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State/province [36]
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pTO aLEGRE
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Brazil
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State/province [37]
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Rio de Janeiro - RJ
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Country [38]
0
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Brazil
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State/province [38]
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São Bernardo do Campo
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Country [39]
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Brazil
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State/province [39]
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São José do Rio Preto
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Country [40]
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Bulgaria
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Plovdiv
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0
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Bulgaria
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Rousse
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Bulgaria
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Sofia
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0
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Bulgaria
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Varna
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0
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Canada
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Alberta
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0
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Canada
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British Columbia
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0
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Canada
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New Brunswick
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0
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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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State/province [48]
0
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Ontario
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Country [49]
0
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Canada
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0
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Quebec
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Country [50]
0
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China
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0
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Beijing
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Country [51]
0
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China
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Chengdu
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0
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China
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Guangzhou
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China
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Hangzhou
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0
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China
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Nanjing
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0
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China
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Shanghai
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0
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China
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Shijiazhuang
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0
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Czech Republic
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0
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Brno
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Country [58]
0
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Czech Republic
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0
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Hradec Kralove
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Country [59]
0
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Czech Republic
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State/province [59]
0
0
Hranice
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0
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Czech Republic
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State/province [60]
0
0
Liberec
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0
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Czech Republic
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State/province [61]
0
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Novy Jicin
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0
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Czech Republic
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State/province [62]
0
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Ostrava-Vitkovice
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Country [63]
0
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Czech Republic
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State/province [63]
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Praha 2
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0
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Czech Republic
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State/province [64]
0
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Tabor
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0
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Czech Republic
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State/province [65]
0
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Usti nad Labem
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Country [66]
0
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Czech Republic
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0
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Zlin
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Country [67]
0
0
Denmark
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State/province [67]
0
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Esbjerg
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Country [68]
0
0
Denmark
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State/province [68]
0
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Holbæk
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0
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Denmark
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State/province [69]
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Kolding
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Country [70]
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Denmark
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København NV
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0
0
Denmark
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0
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København S
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Country [72]
0
0
Denmark
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State/province [72]
0
0
Slagelse
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0
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Finland
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State/province [73]
0
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Espoo
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Country [74]
0
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Finland
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State/province [74]
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Helsinki
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Country [75]
0
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Finland
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State/province [75]
0
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Jyväskylä
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0
0
Finland
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State/province [76]
0
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Kuopio
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0
0
Finland
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State/province [77]
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Tampere
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Country [78]
0
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France
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State/province [78]
0
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Brest Cedex
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France
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State/province [79]
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Lorient
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France
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St Etienne Cedex 2
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France
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State/province [81]
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Vandoeuvre les Nancy
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Germany
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Dresden
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Germany
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Köln
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Germany
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Mannheim
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Germany
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München
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Germany
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State/province [86]
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Püttlingen
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Greece
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0
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Athens
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0
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Hungary
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Budapest
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0
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Hungary
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State/province [89]
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Debrecen
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0
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Hungary
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Gyula
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Hungary
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State/province [91]
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Miskolc
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0
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Hungary
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Pecs
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Hungary
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Szombathely
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Hungary
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State/province [94]
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Székesfehérvár
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India
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new Delhi
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Holon
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Petach Tikva
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Den Bosch
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Heerlen
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Takapuna Auckland 9
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Rud
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Trondheim
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Portugal
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Russian Federation
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Tyumen
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Russian Federation
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Ufa
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Nitra
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Randburg
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Cuenca
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Madrid
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Stockholm
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Sundsvall
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Uppsala
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Kiev
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Vinnitsa
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Ukraine
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Zaporozhye
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United Kingdom
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Headington, Oxford
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Sheffield
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Funding & Sponsors
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Commercial sector/industry
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Name
Boehringer Ingelheim
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Summary
Brief summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
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Trial website
https://clinicaltrials.gov/study/NCT00329238
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Trial related presentations / publications
Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1. Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30. Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.
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Public notes
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Contacts
Principal investigator
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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?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00329238
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