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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00457002




Registration number
NCT00457002
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007
Date last updated
8/12/2015

Titles & IDs
Public title
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Scientific title
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Secondary ID [1] 0 0
CV185-036
Universal Trial Number (UTN)
Trial acronym
ADOPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pulmonary Embolism 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 - Apixaban
Treatment: Drugs - Enoxaparin

Experimental: Arm 1 - While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Active comparator: Arm 2 - While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)


Treatment: Drugs: Apixaban
Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Treatment: Drugs: Enoxaparin
Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
Timepoint [1] 0 0
Intended Treatment Period
Primary outcome [2] 0 0
Incidence of Major Bleeding During the Treatment Period in Treated Participants
Timepoint [2] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [3] 0 0
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [3] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [4] 0 0
Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [4] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [5] 0 0
Incidence of All Bleeding During the Treatment Period in Treated Participants
Timepoint [5] 0 0
Day 1, first dose of drug to last dose of drug plus 2 days
Secondary outcome [1] 0 0
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
Timepoint [1] 0 0
Day 1 to last dose of parenteral study drug plus 1 day
Secondary outcome [2] 0 0
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
Timepoint [2] 0 0
Day 1 to last dose of parenteral study drug plus 1 day
Secondary outcome [3] 0 0
Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [3] 0 0
Intended Treatment Period
Secondary outcome [4] 0 0
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [4] 0 0
Intended Treatment Period
Secondary outcome [5] 0 0
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
Timepoint [5] 0 0
Intended Treatment Period
Secondary outcome [6] 0 0
Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
Timepoint [6] 0 0
Intended Treatment Period
Secondary outcome [7] 0 0
Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [7] 0 0
Intended Treatment Period
Secondary outcome [8] 0 0
Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [8] 0 0
Intended Treatment Period
Secondary outcome [9] 0 0
Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
Timepoint [9] 0 0
Intended Treatment Period
Secondary outcome [10] 0 0
Incidence of Adjudicated PE With Onset During the Intended Treatment Period
Timepoint [10] 0 0
Intended Treatment Period
Secondary outcome [11] 0 0
Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Timepoint [11] 0 0
Intended Treatment Period
Secondary outcome [12] 0 0
Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
Timepoint [12] 0 0
Intended Treatment Period
Secondary outcome [13] 0 0
Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
Timepoint [13] 0 0
Intended Treatment Period
Secondary outcome [14] 0 0
Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
Timepoint [14] 0 0
Intended Treatment Period
Secondary outcome [15] 0 0
Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
Timepoint [15] 0 0
Intended Treatment Period
Secondary outcome [16] 0 0
Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
Timepoint [16] 0 0
Intended Treatment Period
Secondary outcome [17] 0 0
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
Timepoint [17] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Secondary outcome [18] 0 0
Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
Timepoint [18] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [19] 0 0
Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
Timepoint [19] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [20] 0 0
Mean Change From Baseline in Heart Rate in Treated Participants
Timepoint [20] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [21] 0 0
Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
Timepoint [21] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [22] 0 0
Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
Timepoint [22] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [23] 0 0
Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
Timepoint [23] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [24] 0 0
Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
Timepoint [24] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [25] 0 0
Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
Timepoint [25] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [26] 0 0
Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
Timepoint [26] 0 0
Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Secondary outcome [27] 0 0
Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
Timepoint [27] 0 0
Day 1 to last dose of study drug plus 2 days

Eligibility
Key inclusion criteria
* men and non-pregnant, non-breastfeeding women
* 40 years or older
* hospitalized with congestive heart failure or acute respiratory failure
* infection (without septic shock)
* acute rheumatic disorder
* inflammatory bowel disease
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients with venous thromboembolism (VTE)
* active bleeding or at high risk of bleeding
* unable to take oral medication
* with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose = 165 mg/day.

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 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
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
6758
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Concord
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - Kippa Ring
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Woodville
Recruitment hospital [7] 0 0
Local Institution - Box Hill
Recruitment hospital [8] 0 0
Local Institution - Parkville
Recruitment hospital [9] 0 0
Local Institution - Ringwood East
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3135 - Ringwood East
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
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
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
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
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Montana
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Argentina
State/province [30] 0 0
Tucuman
Country [31] 0 0
Argentina
State/province [31] 0 0
Cordoba
Country [32] 0 0
Argentina
State/province [32] 0 0
Corrientes
Country [33] 0 0
Austria
State/province [33] 0 0
Graz
Country [34] 0 0
Austria
State/province [34] 0 0
Wien
Country [35] 0 0
Belgium
State/province [35] 0 0
Waals-Brabant
Country [36] 0 0
Belgium
State/province [36] 0 0
Antwerpen
Country [37] 0 0
Belgium
State/province [37] 0 0
Brasschaat
Country [38] 0 0
Belgium
State/province [38] 0 0
Bruxelles
Country [39] 0 0
Belgium
State/province [39] 0 0
Huy
Country [40] 0 0
Belgium
State/province [40] 0 0
Leuven
Country [41] 0 0
Brazil
State/province [41] 0 0
Minas Gerais
Country [42] 0 0
Brazil
State/province [42] 0 0
Parana
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
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Chile
State/province [47] 0 0
Araucania
Country [48] 0 0
Chile
State/province [48] 0 0
Metropolitana
Country [49] 0 0
Chile
State/province [49] 0 0
Valparaiso
Country [50] 0 0
Colombia
State/province [50] 0 0
Bogota
Country [51] 0 0
Colombia
State/province [51] 0 0
Bucaramanga
Country [52] 0 0
Colombia
State/province [52] 0 0
Medellin
Country [53] 0 0
Czech Republic
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Brno
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Czech Republic
State/province [54] 0 0
Jindrichuv Hradec
Country [55] 0 0
Czech Republic
State/province [55] 0 0
Kladno
Country [56] 0 0
Czech Republic
State/province [56] 0 0
Kyjov
Country [57] 0 0
Czech Republic
State/province [57] 0 0
Ostrava
Country [58] 0 0
Czech Republic
State/province [58] 0 0
Prague 2
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Praha 1
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Praha 5
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Czech Republic
State/province [61] 0 0
Usti Nad Labem
Country [62] 0 0
Denmark
State/province [62] 0 0
Aalborg
Country [63] 0 0
Denmark
State/province [63] 0 0
Aarhus N
Country [64] 0 0
Denmark
State/province [64] 0 0
Arhus C
Country [65] 0 0
Denmark
State/province [65] 0 0
Frederiksberg
Country [66] 0 0
Denmark
State/province [66] 0 0
Glostrup
Country [67] 0 0
Denmark
State/province [67] 0 0
Hellerup
Country [68] 0 0
Denmark
State/province [68] 0 0
Herlev
Country [69] 0 0
Denmark
State/province [69] 0 0
Herning
Country [70] 0 0
Denmark
State/province [70] 0 0
Hvidovre
Country [71] 0 0
Denmark
State/province [71] 0 0
Odense
Country [72] 0 0
Denmark
State/province [72] 0 0
Randers No
Country [73] 0 0
Denmark
State/province [73] 0 0
Silkeborg
Country [74] 0 0
France
State/province [74] 0 0
Bordeaux
Country [75] 0 0
France
State/province [75] 0 0
Brest Cedex
Country [76] 0 0
France
State/province [76] 0 0
Brest
Country [77] 0 0
France
State/province [77] 0 0
Dijon Cedex
Country [78] 0 0
France
State/province [78] 0 0
Grenoble Cedex 9
Country [79] 0 0
France
State/province [79] 0 0
Lille Cedex
Country [80] 0 0
France
State/province [80] 0 0
Nancy
Country [81] 0 0
France
State/province [81] 0 0
Nimes Cedex 9
Country [82] 0 0
France
State/province [82] 0 0
Paris Cedex 10
Country [83] 0 0
France
State/province [83] 0 0
Paris Cedex 15
Country [84] 0 0
France
State/province [84] 0 0
Saint Etienne Cedex 02
Country [85] 0 0
France
State/province [85] 0 0
Vernon
Country [86] 0 0
Germany
State/province [86] 0 0
Bonn
Country [87] 0 0
Germany
State/province [87] 0 0
Coburg
Country [88] 0 0
Germany
State/province [88] 0 0
Darmstadt
Country [89] 0 0
Germany
State/province [89] 0 0
Dresden
Country [90] 0 0
Germany
State/province [90] 0 0
Hannover
Country [91] 0 0
Germany
State/province [91] 0 0
Karlsbad
Country [92] 0 0
Germany
State/province [92] 0 0
Luebeck
Country [93] 0 0
Germany
State/province [93] 0 0
Mannheim
Country [94] 0 0
Germany
State/province [94] 0 0
Offenbach
Country [95] 0 0
Germany
State/province [95] 0 0
Witten
Country [96] 0 0
Hong Kong
State/province [96] 0 0
Shatin, N.T.
Country [97] 0 0
Hungary
State/province [97] 0 0
Budapest
Country [98] 0 0
Hungary
State/province [98] 0 0
Debrecen
Country [99] 0 0
Hungary
State/province [99] 0 0
Dunaujvaros
Country [100] 0 0
Hungary
State/province [100] 0 0
Eger
Country [101] 0 0
India
State/province [101] 0 0
Andhra-Pradesh
Country [102] 0 0
India
State/province [102] 0 0
Andra Pradesh
Country [103] 0 0
India
State/province [103] 0 0
Gujarat
Country [104] 0 0
India
State/province [104] 0 0
Karnataka
Country [105] 0 0
India
State/province [105] 0 0
Madhya Pardesh
Country [106] 0 0
India
State/province [106] 0 0
Maharashtra
Country [107] 0 0
India
State/province [107] 0 0
Maharastra
Country [108] 0 0
India
State/province [108] 0 0
Punjab
Country [109] 0 0
India
State/province [109] 0 0
Tamil Nadu
Country [110] 0 0
India
State/province [110] 0 0
Tamil-Nadu
Country [111] 0 0
India
State/province [111] 0 0
Uttar Pradesh
Country [112] 0 0
India
State/province [112] 0 0
Ahmedabad
Country [113] 0 0
India
State/province [113] 0 0
Bangalore
Country [114] 0 0
India
State/province [114] 0 0
Hyderabad
Country [115] 0 0
India
State/province [115] 0 0
Mumbai
Country [116] 0 0
India
State/province [116] 0 0
New Delhi
Country [117] 0 0
Israel
State/province [117] 0 0
Afula
Country [118] 0 0
Israel
State/province [118] 0 0
Ashkelon
Country [119] 0 0
Israel
State/province [119] 0 0
Beer Sheva
Country [120] 0 0
Israel
State/province [120] 0 0
Haifa
Country [121] 0 0
Israel
State/province [121] 0 0
Petach Tikva
Country [122] 0 0
Israel
State/province [122] 0 0
Safed
Country [123] 0 0
Israel
State/province [123] 0 0
Tel Hashomer
Country [124] 0 0
Israel
State/province [124] 0 0
Tel-Aviv
Country [125] 0 0
Israel
State/province [125] 0 0
Zerifin
Country [126] 0 0
Italy
State/province [126] 0 0
Chieti Scalo
Country [127] 0 0
Italy
State/province [127] 0 0
Cremona
Country [128] 0 0
Italy
State/province [128] 0 0
Padua
Country [129] 0 0
Italy
State/province [129] 0 0
Piacenza
Country [130] 0 0
Italy
State/province [130] 0 0
Reggio Emilia
Country [131] 0 0
Italy
State/province [131] 0 0
Treviso
Country [132] 0 0
Italy
State/province [132] 0 0
Vicenza
Country [133] 0 0
Korea, Republic of
State/province [133] 0 0
Gyeonggi-Do
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Seoul
Country [135] 0 0
Korea, Republic of
State/province [135] 0 0
Suwon
Country [136] 0 0
Malaysia
State/province [136] 0 0
Kelantan
Country [137] 0 0
Malaysia
State/province [137] 0 0
Selangor
Country [138] 0 0
Malaysia
State/province [138] 0 0
Johor Bahru
Country [139] 0 0
Mexico
State/province [139] 0 0
Distrito Federal
Country [140] 0 0
Mexico
State/province [140] 0 0
Nuevo Leon
Country [141] 0 0
Mexico
State/province [141] 0 0
Veracruz
Country [142] 0 0
Mexico
State/province [142] 0 0
Yucatan
Country [143] 0 0
Mexico
State/province [143] 0 0
Queretaro
Country [144] 0 0
Mexico
State/province [144] 0 0
San Luis Potosi
Country [145] 0 0
Netherlands
State/province [145] 0 0
Den Helder
Country [146] 0 0
Norway
State/province [146] 0 0
Kongsvinger
Country [147] 0 0
Peru
State/province [147] 0 0
Lima
Country [148] 0 0
Peru
State/province [148] 0 0
Arequipa
Country [149] 0 0
Peru
State/province [149] 0 0
Callao
Country [150] 0 0
Philippines
State/province [150] 0 0
Misamis Oriental
Country [151] 0 0
Philippines
State/province [151] 0 0
Las Pinas
Country [152] 0 0
Philippines
State/province [152] 0 0
Quezon City
Country [153] 0 0
Poland
State/province [153] 0 0
Bydgoszcz
Country [154] 0 0
Poland
State/province [154] 0 0
Krakow
Country [155] 0 0
Poland
State/province [155] 0 0
Lodz
Country [156] 0 0
Poland
State/province [156] 0 0
Nowa Sol
Country [157] 0 0
Poland
State/province [157] 0 0
Poznan
Country [158] 0 0
Poland
State/province [158] 0 0
Skierniewice
Country [159] 0 0
Poland
State/province [159] 0 0
Warszawa
Country [160] 0 0
Poland
State/province [160] 0 0
Wejherowo
Country [161] 0 0
Poland
State/province [161] 0 0
Zielona Gora
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Moscow
Country [163] 0 0
Russian Federation
State/province [163] 0 0
Odintsovo
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Podolsk
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Ryazan
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Saint Petersburg
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Saint-Petersburg
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Saratov
Country [169] 0 0
Russian Federation
State/province [169] 0 0
St Petersburg
Country [170] 0 0
Russian Federation
State/province [170] 0 0
St. Petersburg
Country [171] 0 0
Russian Federation
State/province [171] 0 0
St.Petersburg
Country [172] 0 0
Singapore
State/province [172] 0 0
Singapore
Country [173] 0 0
South Africa
State/province [173] 0 0
Free State
Country [174] 0 0
South Africa
State/province [174] 0 0
Gauteng
Country [175] 0 0
South Africa
State/province [175] 0 0
Kwa Zulu Natal
Country [176] 0 0
South Africa
State/province [176] 0 0
Western Cape
Country [177] 0 0
South Africa
State/province [177] 0 0
Groenkloof
Country [178] 0 0
Spain
State/province [178] 0 0
Alicante
Country [179] 0 0
Spain
State/province [179] 0 0
Alcorcon(Madrid)
Country [180] 0 0
Spain
State/province [180] 0 0
Barcelona
Country [181] 0 0
Spain
State/province [181] 0 0
Madrid
Country [182] 0 0
Spain
State/province [182] 0 0
Sevilla
Country [183] 0 0
Spain
State/province [183] 0 0
Tarragona
Country [184] 0 0
Sweden
State/province [184] 0 0
Goteborg
Country [185] 0 0
Sweden
State/province [185] 0 0
Lund
Country [186] 0 0
Taiwan
State/province [186] 0 0
Tainan
Country [187] 0 0
Taiwan
State/province [187] 0 0
Taichung
Country [188] 0 0
Turkey
State/province [188] 0 0
Capa
Country [189] 0 0
Turkey
State/province [189] 0 0
Dikimevi
Country [190] 0 0
Turkey
State/province [190] 0 0
Istanbul
Country [191] 0 0
Ukraine
State/province [191] 0 0
Donetsk
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kharkiv
Country [193] 0 0
Ukraine
State/province [193] 0 0
Kharkov
Country [194] 0 0
Ukraine
State/province [194] 0 0
Kyiv
Country [195] 0 0
Ukraine
State/province [195] 0 0
Lutsk
Country [196] 0 0
Ukraine
State/province [196] 0 0
Lviv
Country [197] 0 0
Ukraine
State/province [197] 0 0
Uzhgorod
Country [198] 0 0
Ukraine
State/province [198] 0 0
Vinnitsa
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Greater London
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Middlesex
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Tyne And Wear
Country [202] 0 0
United Kingdom
State/province [202] 0 0
West Midlands
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

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/NCT00457002