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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00391872




Registration number
NCT00391872
Ethics application status
Date submitted
23/10/2006
Date registered
25/10/2006
Date last updated
13/03/2012

Titles & IDs
Public title
A Comparison of Ticagrelor (AZD6140) and Clopidogrel in Patients With Acute Coronary Syndrome
Scientific title
A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of Ticagrelor Compared With Clopidogrel for Prevention of Vascular Events in Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO- a Study of PLATelet Inhibition and Patient Outcomes]
Secondary ID [1] 0 0
PLATO
Secondary ID [2] 0 0
D5130C05262
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ticagrelor
Treatment: Drugs - Clopidogrel

Active comparator: Clopidogrel - Oral treatment

Experimental: Ticagrelor - Oral treatment


Treatment: Drugs: Ticagrelor
Ticagrelor (AZD6140) 90 mg twice daily dose (BD)

Treatment: Drugs: Clopidogrel
Clopidogrel 75 mg once daily dose (ODD)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke
Timepoint [1] 0 0
Randomization up to 12 months
Primary outcome [2] 0 0
Participants With Any Major Bleeding Event
Timepoint [2] 0 0
First dosing up to 12 months
Secondary outcome [1] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI, and Stroke for the Subgroup of Patients With Intent for Invasive Management at Randomization
Timepoint [1] 0 0
Randomization up to 12 months
Secondary outcome [2] 0 0
Participants With Any Event From the Composite of All-cause Mortality, MI, and Stroke
Timepoint [2] 0 0
Randomization up to 12 months
Secondary outcome [3] 0 0
Participants With Any Event From the Composite of Death From Vascular Causes, MI (Including Silent), Stroke, Recurrent Ischemia, Transient Ischemic Attack (TIA) and Other Arterial Thrombotic Events.
Timepoint [3] 0 0
Randomization up to 12 months
Secondary outcome [4] 0 0
Participants With MI Event
Timepoint [4] 0 0
Randomization up to 12 months
Secondary outcome [5] 0 0
Participants With Death From Vascular Causes
Timepoint [5] 0 0
Randomization up to 12 months
Secondary outcome [6] 0 0
Participants With Stroke
Timepoint [6] 0 0
Randomization up to 12 months
Secondary outcome [7] 0 0
Participants With Death From Any Cause
Timepoint [7] 0 0
Randomization up to 12 months
Secondary outcome [8] 0 0
Participants With Non-CABG (Coronary Artery Bypass Graft) Related Major Bleeding
Timepoint [8] 0 0
First dosing up to 12 months
Secondary outcome [9] 0 0
Participants With Major or Minor Bleeding
Timepoint [9] 0 0
First dosing up to 12 months
Secondary outcome [10] 0 0
Participants With Non-procedural Major Bleeding
Timepoint [10] 0 0
First dosing up to 12 months
Secondary outcome [11] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Bleeding
Timepoint [11] 0 0
First dosing up to 12 months
Secondary outcome [12] 0 0
Participants With Coronary Artery Bypass Graft (CABG) Major Fatal/Life-threatening Bleeding
Timepoint [12] 0 0
First dosing up to 12 months
Secondary outcome [13] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24-hour ECG Recorders for 1 Week Following Randomization
Timepoint [13] 0 0
1-week period following randomization
Secondary outcome [14] 0 0
Participants With Ventricular Pauses of Greater Than or Equal to 3 Seconds in Patients Monitored by Holter 24 Hour ECG Recorders for 1 Week at 1 Month Following Randomization
Timepoint [14] 0 0
1-week period following randomization

Eligibility
Key inclusion criteria
* Male or female 18 years or older who has been hospitalised for chest pain and potential ACS
* Females of child-bearing potential must have a negative pregnancy test at enrollment and be willing to use 2 methods of reliable contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Persons with moderate or severe liver disease
* Persons who have already been treated with an invasive (angioplasty) procedure for the current episode of ACS
* Persons who are being treated with blood clotting agents that cannot be stopped

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2009
Sample size
Target
Accrual to date
Final
18624
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Bruce
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Herston
Recruitment hospital [4] 0 0
Research Site - Woolloongabba
Recruitment hospital [5] 0 0
Research Site - Bedford Park
Recruitment hospital [6] 0 0
Research Site - Dandenong
Recruitment hospital [7] 0 0
Research Site - Geelong
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Research Site - Melbourne
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Research Site - Perth
Recruitment postcode(s) [1] 0 0
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- Bedford Park
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- Dandenong
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- Geelong
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- Melbourne
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- Perth
Recruitment outside Australia
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Munster
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Germany
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Germany
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Germany
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ULM
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Germany
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Warendorf
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Germany
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Witten
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Germany
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Wuppertal
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Germany
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Athens
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Larissa
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Patra
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Piraeus
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Cegled
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Hungary
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Debrecen
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Hungary
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Hungary
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Hodmez-vasarhely
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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India
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Delhi
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India
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India
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India
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Kerala
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India
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Madhya Pradesh
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India
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India
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India
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India
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Tamilnadu
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India
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West Bengal
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Bali
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Indonesia
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Jawa Barat
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Indonesia
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Jawa Timur
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Jakarta
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Indonesia
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Indonesia
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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Poriya M.p. Lower Galilee
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Israel
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Israel
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Israel
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CE
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SS
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Korea, Republic of
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Korea, Republic of
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Wilayah Persekutuan
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Mexico
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Mexico
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Mexico
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Mexico
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Plock
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Radom
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Poland
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Tarnow
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Torun
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Poland
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Poland
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Poland
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Poland
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Wloclawek
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Poland
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Wroclaw
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Poland
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Portugal
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Braga
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Portugal
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Portugal
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Portugal
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Santa Maria Da Feira
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Portugal
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Portugal
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Portugal
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Vila Real
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San Juan
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Romania
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Cluj
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Romania
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Braila
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Romania
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Romania
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Romania
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Romania
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Romania
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Iasi
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Romania
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Suceava
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Russian Federation
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Khanty-mansiysk Autonomous Dis
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Irkutsk
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Russian Federation
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Kaliningrad
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Murmansk
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-na-donu
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Singapore
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Singapore
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Bratislava
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Kosice
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Slovakia
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Liptovsky Mikulas
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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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Nove Zamky
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Slovakia
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Piestany
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Slovakia
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Ruzomberok
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Slovakia
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Trnava
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Slovakia
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Free State
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Pretoria
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Spain
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Spain
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Spain
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Spain
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Comunidad de Madrid
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Spain
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Spain
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Spain
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Spain
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Sweden
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Sweden
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Eksjo
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Sweden
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Sweden
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Falun
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Sweden
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Halmstad
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Sweden
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Jonkoping
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sweden
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Sundsvall
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Sweden
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Uppsala
Country [481] 0 0
Sweden
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Country [482] 0 0
Switzerland
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Country [483] 0 0
Switzerland
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Switzerland
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Bern
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Switzerland
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Switzerland
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Switzerland
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Lugano
Country [488] 0 0
Taiwan
State/province [488] 0 0
Kaohsiung
Country [489] 0 0
Taiwan
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Taoyuan Hsien
Country [490] 0 0
Taiwan
State/province [490] 0 0
Taipei
Country [491] 0 0
Thailand
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Bangkok
Country [492] 0 0
Thailand
State/province [492] 0 0
Chiang Mai
Country [493] 0 0
Thailand
State/province [493] 0 0
Khon Kaen
Country [494] 0 0
Turkey
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Kartal
Country [495] 0 0
Turkey
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Sihhiye
Country [496] 0 0
Turkey
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Adana
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Turkey
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Turkey
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Mersin
Country [499] 0 0
Ukraine
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Ukraine
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Ukraine
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Ukraine
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Kiev
Country [503] 0 0
Ukraine
State/province [503] 0 0
Makiyivka
Country [504] 0 0
United Kingdom
State/province [504] 0 0
Lanarkshire
Country [505] 0 0
United Kingdom
State/province [505] 0 0
Northern Ireland
Country [506] 0 0
United Kingdom
State/province [506] 0 0
Basingstoke
Country [507] 0 0
United Kingdom
State/province [507] 0 0
Birmingham
Country [508] 0 0
United Kingdom
State/province [508] 0 0
Blackpool
Country [509] 0 0
United Kingdom
State/province [509] 0 0
Dundee
Country [510] 0 0
United Kingdom
State/province [510] 0 0
Edinburgh
Country [511] 0 0
United Kingdom
State/province [511] 0 0
Glasgow
Country [512] 0 0
United Kingdom
State/province [512] 0 0
Leicester
Country [513] 0 0
United Kingdom
State/province [513] 0 0
London
Country [514] 0 0
United Kingdom
State/province [514] 0 0
Manchester
Country [515] 0 0
United Kingdom
State/province [515] 0 0
Middlesborough
Country [516] 0 0
United Kingdom
State/province [516] 0 0
Poole
Country [517] 0 0
United Kingdom
State/province [517] 0 0
Sheffield
Country [518] 0 0
United Kingdom
State/province [518] 0 0
Swansea

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Robert Harrington, MD
Address 0 0
Duke Clinical Research Institute
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

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/NCT00391872