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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00831441




Registration number
NCT00831441
Ethics application status
Date submitted
28/01/2009
Date registered
29/01/2009
Date last updated
27/01/2016

Titles & IDs
Public title
Phase III Acute Coronary Syndrome
Scientific title
Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
EUDRACT# 2008-008298-77
Secondary ID [2] 0 0
CV185-068
Universal Trial Number (UTN)
Trial acronym
APPRAISE-2
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 - Apixaban
Treatment: Drugs - Placebo

Active comparator: Apixaban -

Placebo comparator: Placebo -


Treatment: Drugs: Apixaban
Tablets, Oral, 5 mg, twice daily, until study end

Treatment: Drugs: Placebo
Tablets, Oral, 0 mg, twice daily, until study end

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [1] 0 0
Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years
Primary outcome [2] 0 0
Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
Timepoint [2] 0 0
From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [1] 0 0
Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
Timepoint [1] 0 0
Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years
Secondary outcome [2] 0 0
Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [2] 0 0
Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years
Secondary outcome [3] 0 0
Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
Timepoint [3] 0 0
Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years
Secondary outcome [4] 0 0
Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
Timepoint [4] 0 0
Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years
Secondary outcome [5] 0 0
Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [5] 0 0
Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years
Secondary outcome [6] 0 0
Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [6] 0 0
Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years
Secondary outcome [7] 0 0
Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Timepoint [7] 0 0
Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years
Secondary outcome [8] 0 0
Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
Timepoint [8] 0 0
From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [9] 0 0
Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
Timepoint [9] 0 0
From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcome [10] 0 0
Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
Timepoint [10] 0 0
From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years

Eligibility
Key inclusion criteria
* Acute coronary syndrome (ACS)
* Clinically stable
* Receiving standard of care for ACS
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe hypertension
* Active bleeding or high risk for major bleeding
* Hemoglobin < 9 g/dL

Study design
Purpose of the study
Prevention
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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Bruce
Recruitment hospital [2] 0 0
Local Institution - Broken Hill
Recruitment hospital [3] 0 0
Local Institution - Kogarah
Recruitment hospital [4] 0 0
Local Institution - Lismore
Recruitment hospital [5] 0 0
Local Institution - Cairns
Recruitment hospital [6] 0 0
Local Institution - Herston
Recruitment hospital [7] 0 0
Local Institution - Milton
Recruitment hospital [8] 0 0
Local Institution - Ashford
Recruitment hospital [9] 0 0
Local Institution - Elizabeth Vale
Recruitment hospital [10] 0 0
Local Institution - Woodville
Recruitment hospital [11] 0 0
Local Institution - Fitzroy
Recruitment hospital [12] 0 0
Local Institution - Geelong
Recruitment hospital [13] 0 0
Local Institution - Richmond
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2880 - Broken Hill
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
4031 - Herston
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
5035 - Ashford
Recruitment postcode(s) [9] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [10] 0 0
5011 - Woodville
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3220 - Geelong
Recruitment postcode(s) [13] 0 0
3121 - Richmond
Recruitment outside Australia
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United States of America
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Szekszard
Country [206] 0 0
Hungary
State/province [206] 0 0
Szentes
Country [207] 0 0
Hungary
State/province [207] 0 0
Szombathely
Country [208] 0 0
Hungary
State/province [208] 0 0
Zalaegerszeg
Country [209] 0 0
India
State/province [209] 0 0
Andhra Pradesh
Country [210] 0 0
India
State/province [210] 0 0
Gujarat
Country [211] 0 0
India
State/province [211] 0 0
Haryana
Country [212] 0 0
India
State/province [212] 0 0
Karnataka
Country [213] 0 0
India
State/province [213] 0 0
Madhya Pradesh
Country [214] 0 0
India
State/province [214] 0 0
Maharashtra
Country [215] 0 0
India
State/province [215] 0 0
Maharastra
Country [216] 0 0
India
State/province [216] 0 0
Punjab
Country [217] 0 0
India
State/province [217] 0 0
Rajasthan
Country [218] 0 0
India
State/province [218] 0 0
Tamil Nadu
Country [219] 0 0
India
State/province [219] 0 0
Tamilnadu
Country [220] 0 0
India
State/province [220] 0 0
Uttar Pradesh
Country [221] 0 0
India
State/province [221] 0 0
Bangalore, Karnataka
Country [222] 0 0
India
State/province [222] 0 0
Bikaner
Country [223] 0 0
India
State/province [223] 0 0
Mangalore
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India
State/province [224] 0 0
New Delhi
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India
State/province [225] 0 0
Pune
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Israel
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Afula
Country [227] 0 0
Israel
State/province [227] 0 0
Ashkelon
Country [228] 0 0
Israel
State/province [228] 0 0
Hadera
Country [229] 0 0
Israel
State/province [229] 0 0
Haifa
Country [230] 0 0
Israel
State/province [230] 0 0
Jerusalem
Country [231] 0 0
Israel
State/province [231] 0 0
Kfar-Saba
Country [232] 0 0
Israel
State/province [232] 0 0
Nahariya
Country [233] 0 0
Israel
State/province [233] 0 0
Nazareth
Country [234] 0 0
Israel
State/province [234] 0 0
Petach Tikva
Country [235] 0 0
Israel
State/province [235] 0 0
Rehovot
Country [236] 0 0
Israel
State/province [236] 0 0
Safed
Country [237] 0 0
Israel
State/province [237] 0 0
Tel Aviv
Country [238] 0 0
Israel
State/province [238] 0 0
Tiberias
Country [239] 0 0
Italy
State/province [239] 0 0
Ascoli Piceno
Country [240] 0 0
Italy
State/province [240] 0 0
Bergamo
Country [241] 0 0
Italy
State/province [241] 0 0
Chieti
Country [242] 0 0
Italy
State/province [242] 0 0
Foggia
Country [243] 0 0
Italy
State/province [243] 0 0
Gravedona (Co)
Country [244] 0 0
Italy
State/province [244] 0 0
Grosseto
Country [245] 0 0
Italy
State/province [245] 0 0
Massa
Country [246] 0 0
Italy
State/province [246] 0 0
Milano
Country [247] 0 0
Italy
State/province [247] 0 0
Milan
Country [248] 0 0
Italy
State/province [248] 0 0
Naples
Country [249] 0 0
Italy
State/province [249] 0 0
Novara
Country [250] 0 0
Italy
State/province [250] 0 0
Pavia
Country [251] 0 0
Italy
State/province [251] 0 0
Perugia
Country [252] 0 0
Italy
State/province [252] 0 0
Roma
Country [253] 0 0
Italy
State/province [253] 0 0
San Daniele Del Friuli (Udine)
Country [254] 0 0
Italy
State/province [254] 0 0
Saronno (Va)
Country [255] 0 0
Italy
State/province [255] 0 0
Verona
Country [256] 0 0
Japan
State/province [256] 0 0
Aichi
Country [257] 0 0
Japan
State/province [257] 0 0
Chiba
Country [258] 0 0
Japan
State/province [258] 0 0
Fukuoka
Country [259] 0 0
Japan
State/province [259] 0 0
Gifu
Country [260] 0 0
Japan
State/province [260] 0 0
Hiroshima
Country [261] 0 0
Japan
State/province [261] 0 0
Hokkaido
Country [262] 0 0
Japan
State/province [262] 0 0
Ibaraki
Country [263] 0 0
Japan
State/province [263] 0 0
Ishikawa
Country [264] 0 0
Japan
State/province [264] 0 0
Kagoshima
Country [265] 0 0
Japan
State/province [265] 0 0
Kanagawa
Country [266] 0 0
Japan
State/province [266] 0 0
Nagano
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Japan
State/province [267] 0 0
Oita
Country [268] 0 0
Japan
State/province [268] 0 0
Osaka
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Japan
State/province [269] 0 0
Saga
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Japan
State/province [270] 0 0
Saitama
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Japan
State/province [271] 0 0
Tokushima
Country [272] 0 0
Japan
State/province [272] 0 0
Tokyo
Country [273] 0 0
Japan
State/province [273] 0 0
Yamaguchi
Country [274] 0 0
Japan
State/province [274] 0 0
Kochi
Country [275] 0 0
Japan
State/province [275] 0 0
Kumamoto
Country [276] 0 0
Japan
State/province [276] 0 0
Kyoto
Country [277] 0 0
Korea, Republic of
State/province [277] 0 0
Gangwon-Do
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Korea, Republic of
State/province [278] 0 0
Gyeongangnam-Do
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Korea, Republic of
State/province [279] 0 0
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Korea, Republic of
State/province [280] 0 0
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Korea, Republic of
State/province [281] 0 0
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Korea, Republic of
State/province [282] 0 0
Goyang
Country [283] 0 0
Korea, Republic of
State/province [283] 0 0
Gwangju
Country [284] 0 0
Korea, Republic of
State/province [284] 0 0
Incheon
Country [285] 0 0
Korea, Republic of
State/province [285] 0 0
Jeonbuk
Country [286] 0 0
Korea, Republic of
State/province [286] 0 0
Pusan
Country [287] 0 0
Korea, Republic of
State/province [287] 0 0
Seoul
Country [288] 0 0
Korea, Republic of
State/province [288] 0 0
Suwon
Country [289] 0 0
Mexico
State/province [289] 0 0
Baja Californa Sur
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Mexico
State/province [290] 0 0
Baja California
Country [291] 0 0
Mexico
State/province [291] 0 0
Coahuila
Country [292] 0 0
Mexico
State/province [292] 0 0
Estado De Mexico
Country [293] 0 0
Mexico
State/province [293] 0 0
Guerrero
Country [294] 0 0
Mexico
State/province [294] 0 0
Hidalgo
Country [295] 0 0
Mexico
State/province [295] 0 0
Jalisco
Country [296] 0 0
Mexico
State/province [296] 0 0
Nuevo Leon
Country [297] 0 0
Mexico
State/province [297] 0 0
Sinaloa
Country [298] 0 0
Mexico
State/province [298] 0 0
Veracruz
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Mexico
State/province [299] 0 0
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Mexico
State/province [300] 0 0
Chihuahua
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Mexico
State/province [301] 0 0
Durango
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Mexico
State/province [302] 0 0
Queretaro
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Mexico
State/province [303] 0 0
San Luis Potosi
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Netherlands
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Netherlands
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Almere
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Netherlands
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Amsterdam
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Netherlands
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Beverwijk
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Netherlands
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Boxmeer
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Netherlands
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Den Haag
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Netherlands
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Dirksland
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Netherlands
State/province [311] 0 0
Ede
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Netherlands
State/province [312] 0 0
Goes
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Netherlands
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Gouda
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Netherlands
State/province [314] 0 0
Heerlen
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Netherlands
State/province [315] 0 0
Hilversum
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Netherlands
State/province [316] 0 0
Maastrict
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Netherlands
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Meppel
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Netherlands
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Purmerend
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Netherlands
State/province [319] 0 0
Sneek
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Netherlands
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Veldhoven
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Netherlands
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Weert
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Netherlands
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Auckland
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New Zealand
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Christchurch
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New Zealand
State/province [325] 0 0
Hastings
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New Zealand
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Nelson
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New Zealand
State/province [327] 0 0
Palmerston North
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Norway
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Bergen
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Norway
State/province [329] 0 0
Bodo
Country [330] 0 0
Norway
State/province [330] 0 0
Drammen
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Norway
State/province [331] 0 0
Hamar
Country [332] 0 0
Norway
State/province [332] 0 0
Kongsvinger
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Norway
State/province [333] 0 0
Kristiansund
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Norway
State/province [334] 0 0
Lillehammer
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Norway
State/province [335] 0 0
Oslo
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Norway
State/province [336] 0 0
Stavanger
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Norway
State/province [337] 0 0
Tynset
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Callao
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Peru
State/province [339] 0 0
Lambayeque
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Peru
State/province [340] 0 0
Cusco
Country [341] 0 0
Peru
State/province [341] 0 0
Ica
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Peru
State/province [342] 0 0
Lima
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Poland
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Mazowiekie
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
State/province [346] 0 0
Bytom
Country [347] 0 0
Poland
State/province [347] 0 0
Czestochowa
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Poland
State/province [348] 0 0
Elblag
Country [349] 0 0
Poland
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Gdynia
Country [350] 0 0
Poland
State/province [350] 0 0
Grodzisk Mazowiecki
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Poland
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Inowroclaw
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Poland
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Kielce
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Poland
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Koscierzyna
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Poland
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Krakow
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Poland
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Lodz
Country [356] 0 0
Poland
State/province [356] 0 0
Lublin
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Poland
State/province [357] 0 0
Opole
Country [358] 0 0
Poland
State/province [358] 0 0
Ostrowiec Swietokrzyski
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Poland
State/province [359] 0 0
Plock
Country [360] 0 0
Poland
State/province [360] 0 0
Poznan
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Poland
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Radom
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Poland
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Rzeszow
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Poland
State/province [363] 0 0
Slupsk
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Poland
State/province [364] 0 0
Szczecin
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Poland
State/province [365] 0 0
Tarnow
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Poland
State/province [366] 0 0
Torun
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Poland
State/province [367] 0 0
Warsaw
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Poland
State/province [368] 0 0
Warszawa
Country [369] 0 0
Poland
State/province [369] 0 0
Wloclawek
Country [370] 0 0
Poland
State/province [370] 0 0
Zabrze
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Poland
State/province [371] 0 0
Zielona Gora
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Puerto Rico
State/province [372] 0 0
Cidra
Country [373] 0 0
Puerto Rico
State/province [373] 0 0
San Juan
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Romania
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Arad
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Romania
State/province [375] 0 0
Baia Mare
Country [376] 0 0
Romania
State/province [376] 0 0
Braila
Country [377] 0 0
Romania
State/province [377] 0 0
Bucharest
Country [378] 0 0
Romania
State/province [378] 0 0
Craiova
Country [379] 0 0
Romania
State/province [379] 0 0
Oradea
Country [380] 0 0
Romania
State/province [380] 0 0
Pitesti
Country [381] 0 0
Romania
State/province [381] 0 0
Sibiu
Country [382] 0 0
Romania
State/province [382] 0 0
Targu Mures
Country [383] 0 0
Romania
State/province [383] 0 0
Timisoara
Country [384] 0 0
Russian Federation
State/province [384] 0 0
Barnaul
Country [385] 0 0
Russian Federation
State/province [385] 0 0
Chelyabinsk
Country [386] 0 0
Russian Federation
State/province [386] 0 0
Ekaterinburg
Country [387] 0 0
Russian Federation
State/province [387] 0 0
Kaluga
Country [388] 0 0
Russian Federation
State/province [388] 0 0
Kazan
Country [389] 0 0
Russian Federation
State/province [389] 0 0
Kemerovo
Country [390] 0 0
Russian Federation
State/province [390] 0 0
Krasnoyarsk
Country [391] 0 0
Russian Federation
State/province [391] 0 0
Moscow Reg. Zhekeznodorozhniy
Country [392] 0 0
Russian Federation
State/province [392] 0 0
Moscow
Country [393] 0 0
Russian Federation
State/province [393] 0 0
Nizhni Novgorod
Country [394] 0 0
Russian Federation
State/province [394] 0 0
Nizhny Novgorod
Country [395] 0 0
Russian Federation
State/province [395] 0 0
Novosibirsk
Country [396] 0 0
Russian Federation
State/province [396] 0 0
Odintsovo
Country [397] 0 0
Russian Federation
State/province [397] 0 0
Penza
Country [398] 0 0
Russian Federation
State/province [398] 0 0
Perm
Country [399] 0 0
Russian Federation
State/province [399] 0 0
Rostov-On-Don
Country [400] 0 0
Russian Federation
State/province [400] 0 0
Ryazan
Country [401] 0 0
Russian Federation
State/province [401] 0 0
Saint Petersburg
Country [402] 0 0
Russian Federation
State/province [402] 0 0
Saint-Petersburg
Country [403] 0 0
Russian Federation
State/province [403] 0 0
Saratov
Country [404] 0 0
Russian Federation
State/province [404] 0 0
St. Petersburg
Country [405] 0 0
Russian Federation
State/province [405] 0 0
Tomsk
Country [406] 0 0
Russian Federation
State/province [406] 0 0
Tver
Country [407] 0 0
Russian Federation
State/province [407] 0 0
Tyumen
Country [408] 0 0
Russian Federation
State/province [408] 0 0
Vasilievsky Island
Country [409] 0 0
Russian Federation
State/province [409] 0 0
Voronezh
Country [410] 0 0
Russian Federation
State/province [410] 0 0
Yaroslavl
Country [411] 0 0
Russian Federation
State/province [411] 0 0
Zhukovskiy
Country [412] 0 0
Singapore
State/province [412] 0 0
Singapore
Country [413] 0 0
Slovakia
State/province [413] 0 0
Banska Bystrica
Country [414] 0 0
Slovakia
State/province [414] 0 0
Bratislava
Country [415] 0 0
Slovakia
State/province [415] 0 0
Kosice
Country [416] 0 0
Slovakia
State/province [416] 0 0
Kralovsky Chlmec
Country [417] 0 0
Slovakia
State/province [417] 0 0
Liptovsky Hradok
Country [418] 0 0
Slovakia
State/province [418] 0 0
Lucenec
Country [419] 0 0
Slovakia
State/province [419] 0 0
Martin
Country [420] 0 0
Slovakia
State/province [420] 0 0
Nitra
Country [421] 0 0
South Africa
State/province [421] 0 0
Eastern Cape
Country [422] 0 0
South Africa
State/province [422] 0 0
Free State
Country [423] 0 0
South Africa
State/province [423] 0 0
Gauteng
Country [424] 0 0
South Africa
State/province [424] 0 0
Kwa Zulu Natal
Country [425] 0 0
South Africa
State/province [425] 0 0
Western Cape
Country [426] 0 0
South Africa
State/province [426] 0 0
Johannesburg
Country [427] 0 0
Spain
State/province [427] 0 0
Alicante
Country [428] 0 0
Spain
State/province [428] 0 0
Asturas
Country [429] 0 0
Spain
State/province [429] 0 0
Gerona
Country [430] 0 0
Spain
State/province [430] 0 0
Madrid
Country [431] 0 0
Spain
State/province [431] 0 0
Almeria
Country [432] 0 0
Spain
State/province [432] 0 0
Barcelona
Country [433] 0 0
Spain
State/province [433] 0 0
Caceres
Country [434] 0 0
Spain
State/province [434] 0 0
El Ejido
Country [435] 0 0
Spain
State/province [435] 0 0
Granada
Country [436] 0 0
Spain
State/province [436] 0 0
Lleida
Country [437] 0 0
Spain
State/province [437] 0 0
Lugo
Country [438] 0 0
Spain
State/province [438] 0 0
Malaga
Country [439] 0 0
Spain
State/province [439] 0 0
Santiago De Compostela
Country [440] 0 0
Spain
State/province [440] 0 0
Sevilla
Country [441] 0 0
Spain
State/province [441] 0 0
Tarragona
Country [442] 0 0
Spain
State/province [442] 0 0
Torrevieja
Country [443] 0 0
Spain
State/province [443] 0 0
Valencia
Country [444] 0 0
Spain
State/province [444] 0 0
Valladolid
Country [445] 0 0
Spain
State/province [445] 0 0
Zaragoza
Country [446] 0 0
Sweden
State/province [446] 0 0
Eskilstuna
Country [447] 0 0
Sweden
State/province [447] 0 0
Halmstad
Country [448] 0 0
Sweden
State/province [448] 0 0
Helsingborg
Country [449] 0 0
Sweden
State/province [449] 0 0
Karlskoga
Country [450] 0 0
Sweden
State/province [450] 0 0
Karlstad
Country [451] 0 0
Sweden
State/province [451] 0 0
Koping
Country [452] 0 0
Sweden
State/province [452] 0 0
Lidkoping
Country [453] 0 0
Sweden
State/province [453] 0 0
Molndal
Country [454] 0 0
Sweden
State/province [454] 0 0
Skovde
Country [455] 0 0
Sweden
State/province [455] 0 0
Stockholm
Country [456] 0 0
Sweden
State/province [456] 0 0
Uppsala
Country [457] 0 0
Sweden
State/province [457] 0 0
Vaxjo
Country [458] 0 0
Switzerland
State/province [458] 0 0
Ticino
Country [459] 0 0
Switzerland
State/province [459] 0 0
Geneve
Country [460] 0 0
Switzerland
State/province [460] 0 0
St Gallen
Country [461] 0 0
Switzerland
State/province [461] 0 0
Zurich
Country [462] 0 0
Turkey
State/province [462] 0 0
Ankara
Country [463] 0 0
Turkey
State/province [463] 0 0
Haseki
Country [464] 0 0
Turkey
State/province [464] 0 0
Izmir
Country [465] 0 0
Turkey
State/province [465] 0 0
Diyarbakir
Country [466] 0 0
Turkey
State/province [466] 0 0
Isparta
Country [467] 0 0
Turkey
State/province [467] 0 0
Kirikkale
Country [468] 0 0
Turkey
State/province [468] 0 0
Konya
Country [469] 0 0
Ukraine
State/province [469] 0 0
Chernivtsy
Country [470] 0 0
Ukraine
State/province [470] 0 0
Dnipropetrovsk
Country [471] 0 0
Ukraine
State/province [471] 0 0
Donetsk
Country [472] 0 0
Ukraine
State/province [472] 0 0
Ivano-Frankivsk
Country [473] 0 0
Ukraine
State/province [473] 0 0
Kharkiv
Country [474] 0 0
Ukraine
State/province [474] 0 0
Kyiv
Country [475] 0 0
Ukraine
State/province [475] 0 0
Lugansk
Country [476] 0 0
Ukraine
State/province [476] 0 0
Lutsk
Country [477] 0 0
Ukraine
State/province [477] 0 0
Lviv
Country [478] 0 0
Ukraine
State/province [478] 0 0
Mykolayiv
Country [479] 0 0
Ukraine
State/province [479] 0 0
Odessa
Country [480] 0 0
Ukraine
State/province [480] 0 0
Simferopol
Country [481] 0 0
Ukraine
State/province [481] 0 0
Vinnitsa
Country [482] 0 0
Ukraine
State/province [482] 0 0
Zhaporizhzhya
Country [483] 0 0
United Kingdom
State/province [483] 0 0
Antrim
Country [484] 0 0
United Kingdom
State/province [484] 0 0
Armagh
Country [485] 0 0
United Kingdom
State/province [485] 0 0
Ayrshire
Country [486] 0 0
United Kingdom
State/province [486] 0 0
Cambridgeshire
Country [487] 0 0
United Kingdom
State/province [487] 0 0
Derbyshire
Country [488] 0 0
United Kingdom
State/province [488] 0 0
Dumfriesshire
Country [489] 0 0
United Kingdom
State/province [489] 0 0
East Yorkshire
Country [490] 0 0
United Kingdom
State/province [490] 0 0
Essex
Country [491] 0 0
United Kingdom
State/province [491] 0 0
Kent
Country [492] 0 0
United Kingdom
State/province [492] 0 0
Lancashire
Country [493] 0 0
United Kingdom
State/province [493] 0 0
Lincolnshire
Country [494] 0 0
United Kingdom
State/province [494] 0 0
Middlesex
Country [495] 0 0
United Kingdom
State/province [495] 0 0
Nottinghamshire
Country [496] 0 0
United Kingdom
State/province [496] 0 0
South Yorkshire
Country [497] 0 0
United Kingdom
State/province [497] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Duke Clinical Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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.