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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00643201




Registration number
NCT00643201
Ethics application status
Date submitted
20/03/2008
Date registered
26/03/2008
Date last updated
21/04/2014

Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Secondary ID [1] 0 0
EUDRACT: 2007-007867-25
Secondary ID [2] 0 0
CV185-056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 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
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin
Treatment: Drugs - warfarin
Treatment: Drugs - Placebo for apixaban
Treatment: Drugs - Placebo for enoxaparin
Treatment: Drugs - Placebo for warfarin
Treatment: Drugs - apixaban

Active comparator: Apixaban - apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Experimental: Enoxaparin + Warfarin - Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) =2.


Treatment: Drugs: Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) =2.

Treatment: Drugs: warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

Treatment: Drugs: Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

Treatment: Drugs: Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR =2.

Treatment: Drugs: Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

Treatment: Drugs: apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
Timepoint [1] 0 0
Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
Secondary outcome [1] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
Timepoint [1] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [2] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
Timepoint [2] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [3] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
Timepoint [3] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [4] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
Timepoint [4] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [5] 0 0
Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
Timepoint [5] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [6] 0 0
Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
Timepoint [6] 0 0
Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [7] 0 0
Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period
Timepoint [7] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [8] 0 0
Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period
Timepoint [8] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [9] 0 0
Incidence of All-Cause Death During the Intended Treatment Period
Timepoint [9] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [10] 0 0
Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
Timepoint [10] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [11] 0 0
Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
Timepoint [11] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [12] 0 0
Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [12] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [13] 0 0
Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
Timepoint [13] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [14] 0 0
Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
Timepoint [14] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [15] 0 0
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
Timepoint [15] 0 0
First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
Secondary outcome [16] 0 0
Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
Timepoint [16] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [17] 0 0
Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
Timepoint [17] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [18] 0 0
Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
Timepoint [18] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [19] 0 0
Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
Timepoint [19] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [20] 0 0
Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
Timepoint [20] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Eligibility
Key inclusion criteria
* Men and women = 18 years of age
* Clinical diagnosis of DVT or PE
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications for enoxaparin or warfarin
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function

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 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
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
5614
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Kogarah
Recruitment hospital [4] 0 0
Local Institution - Lismore
Recruitment hospital [5] 0 0
Local Institution - Randwick
Recruitment hospital [6] 0 0
Local Institution - Herston
Recruitment hospital [7] 0 0
Local Institution - Adelaide
Recruitment hospital [8] 0 0
Local Institution - Bedford Park
Recruitment hospital [9] 0 0
Local Institution - Hobart
Recruitment hospital [10] 0 0
Local Institution - Box Hill
Recruitment hospital [11] 0 0
Local Institution - Clayton
Recruitment hospital [12] 0 0
Local Institution - Ringwood East
Recruitment hospital [13] 0 0
Local Institution - Windsor
Recruitment hospital [14] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
3135 - Ringwood East
Recruitment postcode(s) [13] 0 0
3181 - Windsor
Recruitment postcode(s) [14] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Corrientes
Country [36] 0 0
Austria
State/province [36] 0 0
Graz
Country [37] 0 0
Austria
State/province [37] 0 0
Innsbruck
Country [38] 0 0
Austria
State/province [38] 0 0
Vienna
Country [39] 0 0
Austria
State/province [39] 0 0
Wien
Country [40] 0 0
Brazil
State/province [40] 0 0
Minas Gerais
Country [41] 0 0
Brazil
State/province [41] 0 0
Parana
Country [42] 0 0
Brazil
State/province [42] 0 0
Rio De Janeiro
Country [43] 0 0
Brazil
State/province [43] 0 0
Rio Grande Do Sul
Country [44] 0 0
Brazil
State/province [44] 0 0
Sao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Manitoba
Country [49] 0 0
Canada
State/province [49] 0 0
New Brunswick
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
Magallanes Antartica
Country [53] 0 0
Chile
State/province [53] 0 0
Metropolitana
Country [54] 0 0
Chile
State/province [54] 0 0
Valparaiso
Country [55] 0 0
China
State/province [55] 0 0
Beijing
Country [56] 0 0
China
State/province [56] 0 0
Guangdong
Country [57] 0 0
China
State/province [57] 0 0
Hubei
Country [58] 0 0
China
State/province [58] 0 0
Liaoning
Country [59] 0 0
China
State/province [59] 0 0
Shanghai
Country [60] 0 0
China
State/province [60] 0 0
Zhejiang
Country [61] 0 0
China
State/province [61] 0 0
Xian
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Hradec Kralove
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Kladno
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Litomysl
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Mestec Kralove
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Ostrava Vitkovice
Country [67] 0 0
Czech Republic
State/province [67] 0 0
Ostrava
Country [68] 0 0
Czech Republic
State/province [68] 0 0
Praha 10
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Praha 1
Country [70] 0 0
Czech Republic
State/province [70] 0 0
Praha 2
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Usti Nad Labem
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Usti Nad Orlici
Country [73] 0 0
Denmark
State/province [73] 0 0
Arhus C
Country [74] 0 0
Denmark
State/province [74] 0 0
Hellerup
Country [75] 0 0
Denmark
State/province [75] 0 0
Herning
Country [76] 0 0
Denmark
State/province [76] 0 0
Hilleroed
Country [77] 0 0
Denmark
State/province [77] 0 0
Horsens
Country [78] 0 0
Denmark
State/province [78] 0 0
Naestved
Country [79] 0 0
Denmark
State/province [79] 0 0
Silkeborg
Country [80] 0 0
France
State/province [80] 0 0
Angers
Country [81] 0 0
France
State/province [81] 0 0
Arras
Country [82] 0 0
France
State/province [82] 0 0
Besancon
Country [83] 0 0
France
State/province [83] 0 0
Clamart
Country [84] 0 0
France
State/province [84] 0 0
Clermont-Ferrand Cedex 01
Country [85] 0 0
France
State/province [85] 0 0
Dijon
Country [86] 0 0
France
State/province [86] 0 0
Grenoble Cedex 9
Country [87] 0 0
France
State/province [87] 0 0
Langres Cedex
Country [88] 0 0
France
State/province [88] 0 0
Le Kremlin-Bicetre
Country [89] 0 0
France
State/province [89] 0 0
Lille Cedex
Country [90] 0 0
France
State/province [90] 0 0
Limoges Cedex
Country [91] 0 0
France
State/province [91] 0 0
Nantes
Country [92] 0 0
France
State/province [92] 0 0
Paris
Country [93] 0 0
France
State/province [93] 0 0
Pierre Benite
Country [94] 0 0
France
State/province [94] 0 0
Saint-Priest En Jarez
Country [95] 0 0
France
State/province [95] 0 0
Toulouse cedex 9
Country [96] 0 0
France
State/province [96] 0 0
Vernon
Country [97] 0 0
Germany
State/province [97] 0 0
Berlin
Country [98] 0 0
Germany
State/province [98] 0 0
Bochum
Country [99] 0 0
Germany
State/province [99] 0 0
Cologne
Country [100] 0 0
Germany
State/province [100] 0 0
Dortmund
Country [101] 0 0
Germany
State/province [101] 0 0
Dresden
Country [102] 0 0
Germany
State/province [102] 0 0
Frankfurt
Country [103] 0 0
Germany
State/province [103] 0 0
Gottingen
Country [104] 0 0
Germany
State/province [104] 0 0
Karlsbad
Country [105] 0 0
Germany
State/province [105] 0 0
Ludwigshafen
Country [106] 0 0
Germany
State/province [106] 0 0
Mannheim
Country [107] 0 0
Germany
State/province [107] 0 0
Munchen
Country [108] 0 0
Germany
State/province [108] 0 0
Munich
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Pokfulman
Country [110] 0 0
Hong Kong
State/province [110] 0 0
Shatin, N.T
Country [111] 0 0
Hungary
State/province [111] 0 0
Budapest
Country [112] 0 0
Hungary
State/province [112] 0 0
Gyula
Country [113] 0 0
Hungary
State/province [113] 0 0
Kecskemet
Country [114] 0 0
Hungary
State/province [114] 0 0
Miskolc
Country [115] 0 0
Hungary
State/province [115] 0 0
Mosonmagyarovar
Country [116] 0 0
Hungary
State/province [116] 0 0
Szekesfehervar
Country [117] 0 0
Hungary
State/province [117] 0 0
Zalaegerszeg
Country [118] 0 0
India
State/province [118] 0 0
Andhra Pradesh
Country [119] 0 0
India
State/province [119] 0 0
Gujarat
Country [120] 0 0
India
State/province [120] 0 0
Haryana
Country [121] 0 0
India
State/province [121] 0 0
Karnataka
Country [122] 0 0
India
State/province [122] 0 0
Maharashtra
Country [123] 0 0
India
State/province [123] 0 0
Punjab
Country [124] 0 0
India
State/province [124] 0 0
Tagore Nagar
Country [125] 0 0
India
State/province [125] 0 0
Tamil Nadu
Country [126] 0 0
India
State/province [126] 0 0
Bangalore
Country [127] 0 0
India
State/province [127] 0 0
Pune
Country [128] 0 0
Israel
State/province [128] 0 0
Lower Galillee
Country [129] 0 0
Israel
State/province [129] 0 0
Afula
Country [130] 0 0
Israel
State/province [130] 0 0
Ashkelon
Country [131] 0 0
Israel
State/province [131] 0 0
Hadera
Country [132] 0 0
Israel
State/province [132] 0 0
Haifa
Country [133] 0 0
Israel
State/province [133] 0 0
Holon
Country [134] 0 0
Israel
State/province [134] 0 0
Jerusalem
Country [135] 0 0
Israel
State/province [135] 0 0
Kfar Saba
Country [136] 0 0
Israel
State/province [136] 0 0
Nahariya
Country [137] 0 0
Israel
State/province [137] 0 0
Petach-Tikva
Country [138] 0 0
Israel
State/province [138] 0 0
Rehovot
Country [139] 0 0
Israel
State/province [139] 0 0
Safed
Country [140] 0 0
Israel
State/province [140] 0 0
Tel Aviv
Country [141] 0 0
Israel
State/province [141] 0 0
Tel Hashomer
Country [142] 0 0
Italy
State/province [142] 0 0
Bologna
Country [143] 0 0
Italy
State/province [143] 0 0
Castelfranco Veneto (Tv)
Country [144] 0 0
Italy
State/province [144] 0 0
Chieti Scalo
Country [145] 0 0
Italy
State/province [145] 0 0
Cosenza
Country [146] 0 0
Italy
State/province [146] 0 0
Milano
Country [147] 0 0
Italy
State/province [147] 0 0
Padova
Country [148] 0 0
Italy
State/province [148] 0 0
Palermo
Country [149] 0 0
Italy
State/province [149] 0 0
Pavia
Country [150] 0 0
Italy
State/province [150] 0 0
Piacenza
Country [151] 0 0
Italy
State/province [151] 0 0
Pisa
Country [152] 0 0
Italy
State/province [152] 0 0
Reggio Emilia
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Italy
State/province [153] 0 0
Rome
Country [154] 0 0
Italy
State/province [154] 0 0
Rozzano (Mi)
Country [155] 0 0
Italy
State/province [155] 0 0
San Daniele Del Friuli (Ud)
Country [156] 0 0
Italy
State/province [156] 0 0
Vicenza
Country [157] 0 0
Italy
State/province [157] 0 0
Vittorio Veneto (Tv)
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Busan
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Seoul
Country [160] 0 0
Malaysia
State/province [160] 0 0
Penang
Country [161] 0 0
Malaysia
State/province [161] 0 0
Perak
Country [162] 0 0
Malaysia
State/province [162] 0 0
Kuala Lumpur
Country [163] 0 0
Malaysia
State/province [163] 0 0
Melaka
Country [164] 0 0
Mexico
State/province [164] 0 0
Baja California
Country [165] 0 0
Mexico
State/province [165] 0 0
Guanajuato
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Mexico
State/province [166] 0 0
Jalisco
Country [167] 0 0
Mexico
State/province [167] 0 0
Nuevo Leon
Country [168] 0 0
Mexico
State/province [168] 0 0
Veracruz
Country [169] 0 0
Mexico
State/province [169] 0 0
Aguascalientes
Country [170] 0 0
Mexico
State/province [170] 0 0
Durango
Country [171] 0 0
Norway
State/province [171] 0 0
Alesund
Country [172] 0 0
Norway
State/province [172] 0 0
Fredrikstad
Country [173] 0 0
Norway
State/province [173] 0 0
Gjettum
Country [174] 0 0
Norway
State/province [174] 0 0
Gjovik
Country [175] 0 0
Norway
State/province [175] 0 0
Hamar
Country [176] 0 0
Norway
State/province [176] 0 0
Oslo
Country [177] 0 0
Norway
State/province [177] 0 0
Trondheim
Country [178] 0 0
Norway
State/province [178] 0 0
Tynset
Country [179] 0 0
Poland
State/province [179] 0 0
Bialystok
Country [180] 0 0
Poland
State/province [180] 0 0
Bydgoszcz
Country [181] 0 0
Poland
State/province [181] 0 0
Gdansk
Country [182] 0 0
Poland
State/province [182] 0 0
Gdynia
Country [183] 0 0
Poland
State/province [183] 0 0
Lodz
Country [184] 0 0
Poland
State/province [184] 0 0
Lublin
Country [185] 0 0
Poland
State/province [185] 0 0
Poznan
Country [186] 0 0
Poland
State/province [186] 0 0
Przeworsk
Country [187] 0 0
Poland
State/province [187] 0 0
Szczecin
Country [188] 0 0
Poland
State/province [188] 0 0
Warsawa
Country [189] 0 0
Poland
State/province [189] 0 0
Warsaw
Country [190] 0 0
Poland
State/province [190] 0 0
Warszawa
Country [191] 0 0
Poland
State/province [191] 0 0
Wroclaw
Country [192] 0 0
Portugal
State/province [192] 0 0
Coimbra
Country [193] 0 0
Portugal
State/province [193] 0 0
Guarda
Country [194] 0 0
Portugal
State/province [194] 0 0
Lisboa
Country [195] 0 0
Puerto Rico
State/province [195] 0 0
San Juan
Country [196] 0 0
Romania
State/province [196] 0 0
Baia Mare
Country [197] 0 0
Romania
State/province [197] 0 0
Bucharest
Country [198] 0 0
Romania
State/province [198] 0 0
Targu Mures
Country [199] 0 0
Russian Federation
State/province [199] 0 0
Arkhangelsk
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Chelyabinsk
Country [201] 0 0
Russian Federation
State/province [201] 0 0
Kazan
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Moscow
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Novosibirsk
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Rostov-On Don
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Ryazan
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Saint Petersburg
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Saint-Petersburg
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Saratov
Country [209] 0 0
Russian Federation
State/province [209] 0 0
St Petersburg
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Yaroslavl
Country [211] 0 0
Singapore
State/province [211] 0 0
Singapore
Country [212] 0 0
South Africa
State/province [212] 0 0
Free State
Country [213] 0 0
South Africa
State/province [213] 0 0
Gauteng
Country [214] 0 0
South Africa
State/province [214] 0 0
Kwa Zulu Natal
Country [215] 0 0
South Africa
State/province [215] 0 0
Western Cape
Country [216] 0 0
Spain
State/province [216] 0 0
Alicante
Country [217] 0 0
Spain
State/province [217] 0 0
Getafe
Country [218] 0 0
Spain
State/province [218] 0 0
L'Hospitalet De Llobregat
Country [219] 0 0
Spain
State/province [219] 0 0
Leon
Country [220] 0 0
Spain
State/province [220] 0 0
Madrid
Country [221] 0 0
Spain
State/province [221] 0 0
Malaga
Country [222] 0 0
Spain
State/province [222] 0 0
Mourente
Country [223] 0 0
Spain
State/province [223] 0 0
Tarragona
Country [224] 0 0
Ukraine
State/province [224] 0 0
Chernihiv
Country [225] 0 0
Ukraine
State/province [225] 0 0
Dnipropetrovsk
Country [226] 0 0
Ukraine
State/province [226] 0 0
Donetsk
Country [227] 0 0
Ukraine
State/province [227] 0 0
Ivano-Frankivsk
Country [228] 0 0
Ukraine
State/province [228] 0 0
Kharkiv
Country [229] 0 0
Ukraine
State/province [229] 0 0
Kyiv
Country [230] 0 0
Ukraine
State/province [230] 0 0
Lviv
Country [231] 0 0
Ukraine
State/province [231] 0 0
Odesa
Country [232] 0 0
Ukraine
State/province [232] 0 0
Ternopil
Country [233] 0 0
Ukraine
State/province [233] 0 0
Vinnytsia
Country [234] 0 0
Ukraine
State/province [234] 0 0
Zaporizhzhia
Country [235] 0 0
United Kingdom
State/province [235] 0 0
West Lothian

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

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.

Results are available at https://clinicaltrials.gov/study/NCT00643201