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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02596230




Registration number
NCT02596230
Ethics application status
Date submitted
28/10/2015
Date registered
4/11/2015

Titles & IDs
Public title
RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism
Scientific title
Characterization of Patients Following Acute Venous Thromboembolism (VTE) and Safety and Effectiveness of Dabigatran Etexilate (DE) in the Treatment and Secondary Prevention of Acute Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) in Comparison to Vitamin K Antagonist (VKA) in Routine Clinical Practice - RE-COVERY DVT/PE
Secondary ID [1] 0 0
1160.188
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with acute VTE - Patients will be enrolled for cross sectional characterization of baseline characteristics

Dabigatran - Patients treated with dabigatran for acute VTE will be followed for one year

vitamin K antagonist - Patients treated with VKA for acute VTE will be followed for one year
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective 1: Age
Timepoint [1] 0 0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary outcome [2] 0 0
Objective 1: Sex
Timepoint [2] 0 0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary outcome [3] 0 0
Objective 1: Index Event
Timepoint [3] 0 0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary outcome [4] 0 0
Objective 1: Anticoagulant Treatment
Timepoint [4] 0 0
Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary outcome [5] 0 0
Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs)
Timepoint [5] 0 0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Primary outcome [6] 0 0
Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality
Timepoint [6] 0 0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary outcome [1] 0 0
Objective 2: Incidence Rate of Recurrent DVT and/or PE
Timepoint [1] 0 0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary outcome [2] 0 0
Objective 2: Incidence Rate of VTE-related Mortality
Timepoint [2] 0 0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
Secondary outcome [3] 0 0
Objective 2: Incidence Rate of All-cause Mortality
Timepoint [3] 0 0
12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Written informed consent provided by the patient in accordance with local regulations
2. Diagnosis of an acute DVT and/or PE (For objective 1, assessment of patient for study participation should be done ideally within 14 days but not more than 6 months after diagnosis of the acute VTE. For Objective 2, patient assessment should occur ideally within 14 days but not more than 30 days from diagnosis)
3. Age >= 18 years
4. For Objective 2, the planned anticoagulation therapy should be for at least 3 months
5. For Objective 2, dabigatran and vitamin K antagonist patients should be available for follow-up data collection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Need for anticoagulation therapy for conditions other than venous thromboembolism (VTE)
2. Current participation in a clinical trial for VTE indication or current use of an unapproved drug

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2019
Sample size
Target
Accrual to date
Final
7797
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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United States of America
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Michigan
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Mississippi
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North Carolina
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Pennsylvania
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United States of America
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Tennessee
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Texas
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Temperley
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Austria
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Feldkirch
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Austria
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Graz
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Austria
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Innsbruck
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Lier
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Belgium
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Liège
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Brazil
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Belo Horizonte
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Plovdiv
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Ontario
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Chile
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Santiago
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Colombia
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Armenia
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Cali
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Cartagena
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Colombia
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Manizales
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Colombia
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Medellin
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Czechia
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Beroun
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Czechia
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Brno
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Czechia
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Hodonin
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Louny
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Czechia
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Mlada Boleslav
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Czechia
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Nachod
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Czechia
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Olomouc
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Czechia
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Plzen
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Praha 2
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Czechia
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Praha 4
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Egypt
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Alexandria
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Egypt
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Cairo
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Egypt
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Kalyoub
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Goerlitz
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Germany
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Greifswald
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Germany
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Heidelberg
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Alexandroupolis
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Athens
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Greece
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Ioannina
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Greece
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Larissa
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Greece
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Thessaloniki
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Hungary
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Balassagyarmat
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kistarcsa
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Hungary
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Nagykanizsa
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Hungary
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Pecs
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Hungary
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Szentes
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Hungary
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Szolnok
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Italy
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Acerra
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Italy
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Alba
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Italy
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Bari
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Italy
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Castelfranco Veneto
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Italy
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Faenza (RA)
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Italy
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Lecce
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Italy
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Livorno
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Italy
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Macerata
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Napoli
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Italy
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Italy
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Palermo
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Italy
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Roma
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Sassari
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Varese
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Vimercate (Mi)
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Korea, Republic of
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Anyang-si
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Daugavpils
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Liepaja
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Riga
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Talsi
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Ventspils
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Beirut
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El-Chouf
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Jbeil
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Saida
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Malaysia
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Kota Bahru
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Malaysia
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Kuala Lumpur
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Mexico
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Guadalajara
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Mexico
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San Luis Potosí
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Mexico
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Veracruz
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Netherlands
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Amsterdam
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Breda
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Netherlands
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Nieuwegein
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Netherlands
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Tilburg
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New Zealand
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Palmerston North
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Piura
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Makati
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Manila, Philippines
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Quezon City
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Bydgoszcz
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Bytom
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Romania
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Russian Federation
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Russian Federation
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Russian Federation
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Rostov on Don
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Russian Federation
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St. Petersburg
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Russian Federation
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Russian Federation
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Ufa
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Russian Federation
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Volgograd
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Russian Federation
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Voronezh
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Russian Federation
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Riyadh
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Serbia
State/province [132] 0 0
Belgrade
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Serbia
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Valjevo
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Slovakia
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Bardejov
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Slovakia
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Levice
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Zilina
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Slovenia
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Celje
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Slovenia
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Golnik
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Slovenia
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Maribor
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Slovenia
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Topolsica
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Thailand
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Bangkok
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Thailand
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Pathum Tani
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Turkey
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Ankara
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Turkey
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Bursa
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Turkey
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Diyarbakir
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Turkey
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Gaziantep
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Turkey
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Isparta
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Karaman
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Turkey
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Kayseri
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Turkey
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Rize
Country [158] 0 0
Turkey
State/province [158] 0 0
Yalova
Country [159] 0 0
United Arab Emirates
State/province [159] 0 0
Dubai
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Barnsley
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Basingstoke
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United Kingdom
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Birmingham
Country [163] 0 0
United Kingdom
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Burton on Trent
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United Kingdom
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Durham
Country [165] 0 0
United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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North Shields
Country [168] 0 0
United Kingdom
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Portadown
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United Kingdom
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Salisbury
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh city
Country [172] 0 0
Vietnam
State/province [172] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02596230