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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00403767




Registration number
NCT00403767
Ethics application status
Date submitted
23/11/2006
Date registered
27/11/2006
Date last updated
29/04/2014

Titles & IDs
Public title
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Scientific title
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Secondary ID [1] 0 0
39039039AFL3001
Secondary ID [2] 0 0
CR012157
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Embolism 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban
Treatment: Drugs - Warfarin
Treatment: Drugs - Matching placebo for Rivaroxaban arm (Warfarin placebo)
Treatment: Drugs - Matching placebo for Warfarin arm (Rivaroxaban placebo)

Experimental: Rivaroxaban -

Active comparator: Warfarin -


Treatment: Drugs: Rivaroxaban
Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One 20 mg tablet once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years (Patients with moderate renal impairment at screening willl have a dose adaptation to rivaroxaban 15 mg, orally, once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years)

Treatment: Drugs: Warfarin
Type=exact number, unit=mg, number=1, 2.5, or 5 mg, form=tablet, route=oral use. Number of warfarin tablets to be determined based on target INR values once daily for an expected maximum treatment period of up to 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Rivaroxaban arm (Warfarin placebo)
Form=tablet, route=oral. One warfarin placebo tablet taken orally once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years

Treatment: Drugs: Matching placebo for Warfarin arm (Rivaroxaban placebo)
Form-tablet, Route=oral administration. Number of rivaroxaban placebo determined by the number of warfarin tablets taken. Duration of treatment is up to an expected maximum treatment period of 32 months that may extend up to 4 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
Timepoint [1] 0 0
Up to 4 years
Primary outcome [2] 0 0
The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
Timepoint [2] 0 0
Up to 4 years
Primary outcome [3] 0 0
The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [1] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
Timepoint [2] 0 0
Up to 4 years
Secondary outcome [3] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
Timepoint [3] 0 0
Up to 4 years
Secondary outcome [4] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
Timepoint [4] 0 0
Up to 4 years
Secondary outcome [5] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
Timepoint [5] 0 0
Up to 4 years
Secondary outcome [6] 0 0
The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
Timepoint [6] 0 0
Up to 4 years
Secondary outcome [7] 0 0
All-cause Mortality
Timepoint [7] 0 0
Up to 4 years

Eligibility
Key inclusion criteria
* Patients must have documented atrial fibrillation on 2 separate occasions within 6 months before screening
* History of a prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, or at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Significant mitral stenosis
* Transient atrial fibrillation caused by a reversible disorder
* Active internal bleeding
* Severe disabling stroke
* History of intracranial bleeding
* Hemorrhagic disorders

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 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
1/12/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2010
Sample size
Target
Accrual to date
Final
14269
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Auchenflower
Recruitment hospital [3] 0 0
- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Camperdown
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
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- Miranda
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- Nedlands
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- New Lambton Heights
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- Parkville
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- Penrith
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- Prahran
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- Reservoir
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- Southport
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- Windsor
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- Wolloongabba
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- Adelaide
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- Auchenflower
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- Bedford Park
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- Box Hill
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- Caboolture
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- Cairns
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- Camperdown
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- Chermside
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- Clayton
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- Coffs Harbour
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- Footscray
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- Garran
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- Geelong
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- Gosford
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- Heidelberg Heights
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- Herston
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- Hobart
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- Joondalup
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- Lismore
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- Liverpool
Recruitment postcode(s) [21] 0 0
- Miranda
Recruitment postcode(s) [22] 0 0
- Nedlands
Recruitment postcode(s) [23] 0 0
- New Lambton Heights
Recruitment postcode(s) [24] 0 0
- Parkville
Recruitment postcode(s) [25] 0 0
- Penrith
Recruitment postcode(s) [26] 0 0
- Prahran
Recruitment postcode(s) [27] 0 0
- Reservoir
Recruitment postcode(s) [28] 0 0
- Southport
Recruitment postcode(s) [29] 0 0
- Windsor
Recruitment postcode(s) [30] 0 0
- Wolloongabba
Recruitment outside Australia
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Liberec
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Litomysl
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Czech Republic
State/province [180] 0 0
Praha 4
Country [181] 0 0
Czech Republic
State/province [181] 0 0
Praha 5
Country [182] 0 0
Czech Republic
State/province [182] 0 0
Praha 8
Country [183] 0 0
Czech Republic
State/province [183] 0 0
Praha
Country [184] 0 0
Czech Republic
State/province [184] 0 0
Slany
Country [185] 0 0
Czech Republic
State/province [185] 0 0
Svitavy 2
Country [186] 0 0
Czech Republic
State/province [186] 0 0
Svitavy
Country [187] 0 0
Czech Republic
State/province [187] 0 0
Trutnov
Country [188] 0 0
Czech Republic
State/province [188] 0 0
Uherské Hradistì 6
Country [189] 0 0
Czech Republic
State/province [189] 0 0
Zlín 1
Country [190] 0 0
Denmark
State/province [190] 0 0
Esbjerg
Country [191] 0 0
Denmark
State/province [191] 0 0
Frederiksberg
Country [192] 0 0
Denmark
State/province [192] 0 0
Gentofte
Country [193] 0 0
Denmark
State/province [193] 0 0
Hellerup
Country [194] 0 0
Denmark
State/province [194] 0 0
Helsingør
Country [195] 0 0
Denmark
State/province [195] 0 0
Hvidovre
Country [196] 0 0
Denmark
State/province [196] 0 0
Koege
Country [197] 0 0
Denmark
State/province [197] 0 0
København
Country [198] 0 0
Denmark
State/province [198] 0 0
Næstved
Country [199] 0 0
Denmark
State/province [199] 0 0
Roskilde
Country [200] 0 0
Denmark
State/province [200] 0 0
Slagelse
Country [201] 0 0
Denmark
State/province [201] 0 0
Viborg
Country [202] 0 0
Finland
State/province [202] 0 0
Helsinki
Country [203] 0 0
Finland
State/province [203] 0 0
Jyväskylä N/A
Country [204] 0 0
Finland
State/province [204] 0 0
Kuopio
Country [205] 0 0
Finland
State/province [205] 0 0
Mikkeli
Country [206] 0 0
Finland
State/province [206] 0 0
Oulu
Country [207] 0 0
Finland
State/province [207] 0 0
Turku
Country [208] 0 0
France
State/province [208] 0 0
Albi
Country [209] 0 0
France
State/province [209] 0 0
Arras
Country [210] 0 0
France
State/province [210] 0 0
Bayonne
Country [211] 0 0
France
State/province [211] 0 0
Belfort
Country [212] 0 0
France
State/province [212] 0 0
Besancon N/A
Country [213] 0 0
France
State/province [213] 0 0
Bourg En Bresse
Country [214] 0 0
France
State/province [214] 0 0
Brest
Country [215] 0 0
France
State/province [215] 0 0
Béziers Languedoc-Roussillon
Country [216] 0 0
France
State/province [216] 0 0
Carcassonne
Country [217] 0 0
France
State/province [217] 0 0
Clermont Ferrand
Country [218] 0 0
France
State/province [218] 0 0
Corbeil Essonnes
Country [219] 0 0
France
State/province [219] 0 0
Lille
Country [220] 0 0
France
State/province [220] 0 0
Marseille
Country [221] 0 0
France
State/province [221] 0 0
Montbeliard
Country [222] 0 0
France
State/province [222] 0 0
Montpellier
Country [223] 0 0
France
State/province [223] 0 0
Paris Cedex 14
Country [224] 0 0
France
State/province [224] 0 0
Paris
Country [225] 0 0
France
State/province [225] 0 0
Perpignan
Country [226] 0 0
France
State/province [226] 0 0
Poitiers
Country [227] 0 0
France
State/province [227] 0 0
Saint-Brieuc
Country [228] 0 0
France
State/province [228] 0 0
St Jean De Verges
Country [229] 0 0
France
State/province [229] 0 0
Strasbourg
Country [230] 0 0
France
State/province [230] 0 0
Thionville
Country [231] 0 0
France
State/province [231] 0 0
Toulouse
Country [232] 0 0
France
State/province [232] 0 0
Trelivan
Country [233] 0 0
Germany
State/province [233] 0 0
Aalen
Country [234] 0 0
Germany
State/province [234] 0 0
Berlin/Spandau
Country [235] 0 0
Germany
State/province [235] 0 0
Berlin
Country [236] 0 0
Germany
State/province [236] 0 0
Biberach
Country [237] 0 0
Germany
State/province [237] 0 0
Bochum
Country [238] 0 0
Germany
State/province [238] 0 0
Bonn
Country [239] 0 0
Germany
State/province [239] 0 0
Chemnitz
Country [240] 0 0
Germany
State/province [240] 0 0
Coburg
Country [241] 0 0
Germany
State/province [241] 0 0
Dachau
Country [242] 0 0
Germany
State/province [242] 0 0
Dortmund
Country [243] 0 0
Germany
State/province [243] 0 0
Dresden
Country [244] 0 0
Germany
State/province [244] 0 0
Duisburg
Country [245] 0 0
Germany
State/province [245] 0 0
Ebersbach
Country [246] 0 0
Germany
State/province [246] 0 0
Eilenburg
Country [247] 0 0
Germany
State/province [247] 0 0
Erfurt
Country [248] 0 0
Germany
State/province [248] 0 0
Essen
Country [249] 0 0
Germany
State/province [249] 0 0
Frankfurt
Country [250] 0 0
Germany
State/province [250] 0 0
Freiburg
Country [251] 0 0
Germany
State/province [251] 0 0
Greifswald
Country [252] 0 0
Germany
State/province [252] 0 0
Halle
Country [253] 0 0
Germany
State/province [253] 0 0
Hamburg
Country [254] 0 0
Germany
State/province [254] 0 0
Hartmannsdorf
Country [255] 0 0
Germany
State/province [255] 0 0
Heidelberg
Country [256] 0 0
Germany
State/province [256] 0 0
Henstedt-Rhen
Country [257] 0 0
Germany
State/province [257] 0 0
Herford
Country [258] 0 0
Germany
State/province [258] 0 0
Homburg/Saar
Country [259] 0 0
Germany
State/province [259] 0 0
Jena
Country [260] 0 0
Germany
State/province [260] 0 0
Julich
Country [261] 0 0
Germany
State/province [261] 0 0
Kamen
Country [262] 0 0
Germany
State/province [262] 0 0
Karlsbad
Country [263] 0 0
Germany
State/province [263] 0 0
Kassel
Country [264] 0 0
Germany
State/province [264] 0 0
Kirchzarten
Country [265] 0 0
Germany
State/province [265] 0 0
Krefeld
Country [266] 0 0
Germany
State/province [266] 0 0
Leipzig
Country [267] 0 0
Germany
State/province [267] 0 0
Ludwigsburg
Country [268] 0 0
Germany
State/province [268] 0 0
Ludwigshafen
Country [269] 0 0
Germany
State/province [269] 0 0
Lüneburg
Country [270] 0 0
Germany
State/province [270] 0 0
Magdeburg
Country [271] 0 0
Germany
State/province [271] 0 0
Mainz
Country [272] 0 0
Germany
State/province [272] 0 0
Mannheim
Country [273] 0 0
Germany
State/province [273] 0 0
Markkleeberg
Country [274] 0 0
Germany
State/province [274] 0 0
Meißen
Country [275] 0 0
Germany
State/province [275] 0 0
Melsungen
Country [276] 0 0
Germany
State/province [276] 0 0
Monchengladbach
Country [277] 0 0
Germany
State/province [277] 0 0
Munchen
Country [278] 0 0
Germany
State/province [278] 0 0
Mühldorf
Country [279] 0 0
Germany
State/province [279] 0 0
Mülheim
Country [280] 0 0
Germany
State/province [280] 0 0
Münster
Country [281] 0 0
Germany
State/province [281] 0 0
Neuwied
Country [282] 0 0
Germany
State/province [282] 0 0
Nienburg
Country [283] 0 0
Germany
State/province [283] 0 0
Nuernberg
Country [284] 0 0
Germany
State/province [284] 0 0
Paderborn
Country [285] 0 0
Germany
State/province [285] 0 0
Potsdam
Country [286] 0 0
Germany
State/province [286] 0 0
Riesa
Country [287] 0 0
Germany
State/province [287] 0 0
Rottweil
Country [288] 0 0
Germany
State/province [288] 0 0
Sachsen
Country [289] 0 0
Germany
State/province [289] 0 0
Siegen
Country [290] 0 0
Germany
State/province [290] 0 0
Ulm
Country [291] 0 0
Germany
State/province [291] 0 0
Wermsdorf
Country [292] 0 0
Germany
State/province [292] 0 0
Witten
Country [293] 0 0
Germany
State/province [293] 0 0
Wolmirstedt
Country [294] 0 0
Germany
State/province [294] 0 0
Wuppertal
Country [295] 0 0
Greece
State/province [295] 0 0
Athens Attica
Country [296] 0 0
Greece
State/province [296] 0 0
Ioannina
Country [297] 0 0
Greece
State/province [297] 0 0
Maroussi Athens
Country [298] 0 0
Greece
State/province [298] 0 0
Patra
Country [299] 0 0
Greece
State/province [299] 0 0
Piraeus Attica
Country [300] 0 0
Greece
State/province [300] 0 0
Tripoli
Country [301] 0 0
Greece
State/province [301] 0 0
Voula Attica
Country [302] 0 0
Hong Kong
State/province [302] 0 0
Aberdeen
Country [303] 0 0
Hong Kong
State/province [303] 0 0
Hk
Country [304] 0 0
Hong Kong
State/province [304] 0 0
Kln
Country [305] 0 0
Hong Kong
State/province [305] 0 0
Sha Tin
Country [306] 0 0
Hungary
State/province [306] 0 0
Budapest N/A
Country [307] 0 0
Hungary
State/province [307] 0 0
Budapest Nap
Country [308] 0 0
Hungary
State/province [308] 0 0
Budapest
Country [309] 0 0
Hungary
State/province [309] 0 0
Debrecen County
Country [310] 0 0
Hungary
State/province [310] 0 0
Eger
Country [311] 0 0
Hungary
State/province [311] 0 0
Gyongyos
Country [312] 0 0
Hungary
State/province [312] 0 0
Gyõr
Country [313] 0 0
Hungary
State/province [313] 0 0
Kesckemet
Country [314] 0 0
Hungary
State/province [314] 0 0
Miskolc
Country [315] 0 0
Hungary
State/province [315] 0 0
Nyiregyhaza
Country [316] 0 0
Hungary
State/province [316] 0 0
Pecs
Country [317] 0 0
Hungary
State/province [317] 0 0
Szeged
Country [318] 0 0
Hungary
State/province [318] 0 0
Szekszard
Country [319] 0 0
Hungary
State/province [319] 0 0
Szombathely
Country [320] 0 0
Hungary
State/province [320] 0 0
Veszprem
Country [321] 0 0
Hungary
State/province [321] 0 0
Zalaegerszeg
Country [322] 0 0
India
State/province [322] 0 0
Ahmedabad
Country [323] 0 0
India
State/province [323] 0 0
Bangalore
Country [324] 0 0
India
State/province [324] 0 0
Bikaner
Country [325] 0 0
India
State/province [325] 0 0
Chennai
Country [326] 0 0
India
State/province [326] 0 0
Coimbatore
Country [327] 0 0
India
State/province [327] 0 0
Gandhinagar Guiarat
Country [328] 0 0
India
State/province [328] 0 0
Hyderabad Andra Pradesh
Country [329] 0 0
India
State/province [329] 0 0
Hyderabad
Country [330] 0 0
India
State/province [330] 0 0
Jalandhar
Country [331] 0 0
India
State/province [331] 0 0
Madurai
Country [332] 0 0
India
State/province [332] 0 0
Mangalore
Country [333] 0 0
India
State/province [333] 0 0
Mumbai
Country [334] 0 0
India
State/province [334] 0 0
Mysore
Country [335] 0 0
India
State/province [335] 0 0
New Delhi
Country [336] 0 0
India
State/province [336] 0 0
Pune
Country [337] 0 0
India
State/province [337] 0 0
Suraj
Country [338] 0 0
India
State/province [338] 0 0
Vadodara
Country [339] 0 0
India
State/province [339] 0 0
Vishakapatnam
Country [340] 0 0
Israel
State/province [340] 0 0
Afula
Country [341] 0 0
Israel
State/province [341] 0 0
Ashkelon
Country [342] 0 0
Israel
State/province [342] 0 0
Hadera
Country [343] 0 0
Israel
State/province [343] 0 0
Haifa
Country [344] 0 0
Israel
State/province [344] 0 0
Holon
Country [345] 0 0
Israel
State/province [345] 0 0
Jerusalem
Country [346] 0 0
Israel
State/province [346] 0 0
Nazareth
Country [347] 0 0
Israel
State/province [347] 0 0
Netanya
Country [348] 0 0
Israel
State/province [348] 0 0
Petach-Tikva
Country [349] 0 0
Israel
State/province [349] 0 0
Petah-Tikva
Country [350] 0 0
Israel
State/province [350] 0 0
Poriya
Country [351] 0 0
Israel
State/province [351] 0 0
Rehovot
Country [352] 0 0
Israel
State/province [352] 0 0
Safed
Country [353] 0 0
Israel
State/province [353] 0 0
Tel Aviv
Country [354] 0 0
Israel
State/province [354] 0 0
Tel Hashomer
Country [355] 0 0
Israel
State/province [355] 0 0
Zerifin
Country [356] 0 0
Korea, Republic of
State/province [356] 0 0
Anyang
Country [357] 0 0
Korea, Republic of
State/province [357] 0 0
Daegu
Country [358] 0 0
Korea, Republic of
State/province [358] 0 0
Daejeon
Country [359] 0 0
Korea, Republic of
State/province [359] 0 0
Goyang
Country [360] 0 0
Korea, Republic of
State/province [360] 0 0
Kyonggi-Do
Country [361] 0 0
Korea, Republic of
State/province [361] 0 0
Pusan
Country [362] 0 0
Korea, Republic of
State/province [362] 0 0
Seoul
Country [363] 0 0
Korea, Republic of
State/province [363] 0 0
Sungnam
Country [364] 0 0
Korea, Republic of
State/province [364] 0 0
Suwon
Country [365] 0 0
Lithuania
State/province [365] 0 0
Kaunas
Country [366] 0 0
Lithuania
State/province [366] 0 0
Klaipeda
Country [367] 0 0
Lithuania
State/province [367] 0 0
Panevezys
Country [368] 0 0
Lithuania
State/province [368] 0 0
Siauliai
Country [369] 0 0
Lithuania
State/province [369] 0 0
Vilnius
Country [370] 0 0
Malaysia
State/province [370] 0 0
Kelantan
Country [371] 0 0
Malaysia
State/province [371] 0 0
Kuala Lumpur
Country [372] 0 0
Malaysia
State/province [372] 0 0
Sarawak
Country [373] 0 0
Mexico
State/province [373] 0 0
Aguascalientes
Country [374] 0 0
Mexico
State/province [374] 0 0
Ciudad De Mexico
Country [375] 0 0
Mexico
State/province [375] 0 0
Culiacán Sinaloa/Mèxico
Country [376] 0 0
Mexico
State/province [376] 0 0
Guadalajara
Country [377] 0 0
Mexico
State/province [377] 0 0
Hermosillo
Country [378] 0 0
Mexico
State/province [378] 0 0
Monterrey Nuevo Leòn
Country [379] 0 0
Mexico
State/province [379] 0 0
Monterrey
Country [380] 0 0
Mexico
State/province [380] 0 0
Queretaro
Country [381] 0 0
Mexico
State/province [381] 0 0
San Luis Potosi
Country [382] 0 0
Mexico
State/province [382] 0 0
Sinaloa
Country [383] 0 0
Mexico
State/province [383] 0 0
Zapopan
Country [384] 0 0
Netherlands
State/province [384] 0 0
'S-Gravenhage
Country [385] 0 0
Netherlands
State/province [385] 0 0
Alkmaar
Country [386] 0 0
Netherlands
State/province [386] 0 0
Amersfoort
Country [387] 0 0
Netherlands
State/province [387] 0 0
Amsterdam
Country [388] 0 0
Netherlands
State/province [388] 0 0
Blaricum
Country [389] 0 0
Netherlands
State/province [389] 0 0
Delft
Country [390] 0 0
Netherlands
State/province [390] 0 0
Den Bosch
Country [391] 0 0
Netherlands
State/province [391] 0 0
Den Haag
Country [392] 0 0
Netherlands
State/province [392] 0 0
Gc Tilburg
Country [393] 0 0
Netherlands
State/province [393] 0 0
Gouda
Country [394] 0 0
Netherlands
State/province [394] 0 0
Groningen
Country [395] 0 0
Netherlands
State/province [395] 0 0
Haarlem
Country [396] 0 0
Netherlands
State/province [396] 0 0
Heerlen
Country [397] 0 0
Netherlands
State/province [397] 0 0
Hoofddorp
Country [398] 0 0
Netherlands
State/province [398] 0 0
Hoorn Nh
Country [399] 0 0
Netherlands
State/province [399] 0 0
Leeuwarden
Country [400] 0 0
Netherlands
State/province [400] 0 0
Leidschendam
Country [401] 0 0
Netherlands
State/province [401] 0 0
Maastricht
Country [402] 0 0
Netherlands
State/province [402] 0 0
Meppel
Country [403] 0 0
Netherlands
State/province [403] 0 0
Nijmegen
Country [404] 0 0
Netherlands
State/province [404] 0 0
Schiedam
Country [405] 0 0
Netherlands
State/province [405] 0 0
Veldhoven
Country [406] 0 0
New Zealand
State/province [406] 0 0
Christchurch
Country [407] 0 0
New Zealand
State/province [407] 0 0
Dunedin
Country [408] 0 0
New Zealand
State/province [408] 0 0
Grafton
Country [409] 0 0
New Zealand
State/province [409] 0 0
Hamilton
Country [410] 0 0
New Zealand
State/province [410] 0 0
Takapuna Auckland
Country [411] 0 0
New Zealand
State/province [411] 0 0
Wellington
Country [412] 0 0
Norway
State/province [412] 0 0
Alesund
Country [413] 0 0
Norway
State/province [413] 0 0
Bergen
Country [414] 0 0
Norway
State/province [414] 0 0
Elverum
Country [415] 0 0
Norway
State/province [415] 0 0
Hamar
Country [416] 0 0
Norway
State/province [416] 0 0
Jessheim
Country [417] 0 0
Norway
State/province [417] 0 0
Lillehammer
Country [418] 0 0
Norway
State/province [418] 0 0
Moss
Country [419] 0 0
Norway
State/province [419] 0 0
Oslo
Country [420] 0 0
Norway
State/province [420] 0 0
Sandefjord
Country [421] 0 0
Norway
State/province [421] 0 0
Sandnes
Country [422] 0 0
Norway
State/province [422] 0 0
Sandvika
Country [423] 0 0
Norway
State/province [423] 0 0
Skedsmokorset
Country [424] 0 0
Peru
State/province [424] 0 0
L41 Lima Lima
Country [425] 0 0
Peru
State/province [425] 0 0
Lima 1 Lima Lima
Country [426] 0 0
Peru
State/province [426] 0 0
Lima
Country [427] 0 0
Philippines
State/province [427] 0 0
Cebuu City
Country [428] 0 0
Philippines
State/province [428] 0 0
Davao City
Country [429] 0 0
Philippines
State/province [429] 0 0
Iloilo City
Country [430] 0 0
Philippines
State/province [430] 0 0
Manila City
Country [431] 0 0
Philippines
State/province [431] 0 0
Quezon City
Country [432] 0 0
Poland
State/province [432] 0 0
Bydgoszcz N/A
Country [433] 0 0
Poland
State/province [433] 0 0
Bydgoszcz
Country [434] 0 0
Poland
State/province [434] 0 0
Gdansk
Country [435] 0 0
Poland
State/province [435] 0 0
Gdynia
Country [436] 0 0
Poland
State/province [436] 0 0
Katowice-Ochojec
Country [437] 0 0
Poland
State/province [437] 0 0
Katowice
Country [438] 0 0
Poland
State/province [438] 0 0
Krakow
Country [439] 0 0
Poland
State/province [439] 0 0
Lodz
Country [440] 0 0
Poland
State/province [440] 0 0
Olawa
Country [441] 0 0
Poland
State/province [441] 0 0
Olsztyn
Country [442] 0 0
Poland
State/province [442] 0 0
Opole
Country [443] 0 0
Poland
State/province [443] 0 0
Ostrowiec N/A
Country [444] 0 0
Poland
State/province [444] 0 0
Piotrkow Trybunalski
Country [445] 0 0
Poland
State/province [445] 0 0
Plock
Country [446] 0 0
Poland
State/province [446] 0 0
Poznan
Country [447] 0 0
Poland
State/province [447] 0 0
Siedlce
Country [448] 0 0
Poland
State/province [448] 0 0
Sieradz N/A
Country [449] 0 0
Poland
State/province [449] 0 0
Skierniewice
Country [450] 0 0
Poland
State/province [450] 0 0
Starogard Gdanski Nap
Country [451] 0 0
Poland
State/province [451] 0 0
Szczecin Nap
Country [452] 0 0
Poland
State/province [452] 0 0
Szczecin
Country [453] 0 0
Poland
State/province [453] 0 0
Torun
Country [454] 0 0
Poland
State/province [454] 0 0
Warsaw
Country [455] 0 0
Poland
State/province [455] 0 0
Warszawa N/A
Country [456] 0 0
Poland
State/province [456] 0 0
Warszawa
Country [457] 0 0
Poland
State/province [457] 0 0
Wloclawek
Country [458] 0 0
Poland
State/province [458] 0 0
Wroclaw N/A
Country [459] 0 0
Poland
State/province [459] 0 0
Wroclaw
Country [460] 0 0
Poland
State/province [460] 0 0
Zyrardow N/A
Country [461] 0 0
Romania
State/province [461] 0 0
Brasov
Country [462] 0 0
Romania
State/province [462] 0 0
Bucharest
Country [463] 0 0
Romania
State/province [463] 0 0
Bucuresti
Country [464] 0 0
Romania
State/province [464] 0 0
Craiova
Country [465] 0 0
Romania
State/province [465] 0 0
Focsani
Country [466] 0 0
Romania
State/province [466] 0 0
Iasi
Country [467] 0 0
Romania
State/province [467] 0 0
Oradea
Country [468] 0 0
Romania
State/province [468] 0 0
Sibiu
Country [469] 0 0
Romania
State/province [469] 0 0
Suceava
Country [470] 0 0
Romania
State/province [470] 0 0
Tg Mures
Country [471] 0 0
Romania
State/province [471] 0 0
Timisoara
Country [472] 0 0
Russian Federation
State/province [472] 0 0
Barnaul
Country [473] 0 0
Russian Federation
State/province [473] 0 0
Chelyabinsk Chelyabinsk Region
Country [474] 0 0
Russian Federation
State/province [474] 0 0
Chelyabinsk
Country [475] 0 0
Russian Federation
State/province [475] 0 0
Ekaterinburg
Country [476] 0 0
Russian Federation
State/province [476] 0 0
Kemerovo
Country [477] 0 0
Russian Federation
State/province [477] 0 0
Krasnoyarsk
Country [478] 0 0
Russian Federation
State/province [478] 0 0
Moscow N/A
Country [479] 0 0
Russian Federation
State/province [479] 0 0
Moscow
Country [480] 0 0
Russian Federation
State/province [480] 0 0
Nizhni Novgorod
Country [481] 0 0
Russian Federation
State/province [481] 0 0
Novosibirsk Nap
Country [482] 0 0
Russian Federation
State/province [482] 0 0
Novosibirsk
Country [483] 0 0
Russian Federation
State/province [483] 0 0
Orenburg
Country [484] 0 0
Russian Federation
State/province [484] 0 0
Perm
Country [485] 0 0
Russian Federation
State/province [485] 0 0
Ryazan
Country [486] 0 0
Russian Federation
State/province [486] 0 0
Saint Petersburg
Country [487] 0 0
Russian Federation
State/province [487] 0 0
Saint-Petersburg
Country [488] 0 0
Russian Federation
State/province [488] 0 0
Saratov
Country [489] 0 0
Russian Federation
State/province [489] 0 0
Smolensk
Country [490] 0 0
Russian Federation
State/province [490] 0 0
St Petersburg
Country [491] 0 0
Russian Federation
State/province [491] 0 0
St. Petersburg
Country [492] 0 0
Russian Federation
State/province [492] 0 0
Tomsk
Country [493] 0 0
Russian Federation
State/province [493] 0 0
Tyumen Tyumen Region
Country [494] 0 0
Russian Federation
State/province [494] 0 0
Yaroslavl Nap
Country [495] 0 0
Russian Federation
State/province [495] 0 0
Yaroslavl
Country [496] 0 0
Singapore
State/province [496] 0 0
Singapore
Country [497] 0 0
South Africa
State/province [497] 0 0
Bloemfontein Free State
Country [498] 0 0
South Africa
State/province [498] 0 0
Bloemfontein Orange Free State
Country [499] 0 0
South Africa
State/province [499] 0 0
Cape Town Western Cape
Country [500] 0 0
South Africa
State/province [500] 0 0
Cape Town
Country [501] 0 0
South Africa
State/province [501] 0 0
Centurion Gauteng
Country [502] 0 0
South Africa
State/province [502] 0 0
Durban Kwa Zulu Natal
Country [503] 0 0
South Africa
State/province [503] 0 0
Johannesburg Gauteng
Country [504] 0 0
South Africa
State/province [504] 0 0
Kempton Park Gauteng
Country [505] 0 0
South Africa
State/province [505] 0 0
Port Elizabeth Eastern Cape
Country [506] 0 0
South Africa
State/province [506] 0 0
Pretoria Gauteng
Country [507] 0 0
South Africa
State/province [507] 0 0
Somerset West Western Cape
Country [508] 0 0
South Africa
State/province [508] 0 0
Van Der Bijl Park
Country [509] 0 0
South Africa
State/province [509] 0 0
Worcester Western Cape
Country [510] 0 0
Spain
State/province [510] 0 0
A Coruna
Country [511] 0 0
Spain
State/province [511] 0 0
Alicante N/A
Country [512] 0 0
Spain
State/province [512] 0 0
Almeria
Country [513] 0 0
Spain
State/province [513] 0 0
Baracaldo Vizcaya
Country [514] 0 0
Spain
State/province [514] 0 0
Barcelona
Country [515] 0 0
Spain
State/province [515] 0 0
Burgos
Country [516] 0 0
Spain
State/province [516] 0 0
Guadalajara
Country [517] 0 0
Spain
State/province [517] 0 0
La Corona
Country [518] 0 0
Spain
State/province [518] 0 0
Madrid
Country [519] 0 0
Spain
State/province [519] 0 0
Malaga
Country [520] 0 0
Spain
State/province [520] 0 0
Oviedo
Country [521] 0 0
Spain
State/province [521] 0 0
Palma De Mallorca
Country [522] 0 0
Spain
State/province [522] 0 0
Pamplona
Country [523] 0 0
Spain
State/province [523] 0 0
Pontevedra
Country [524] 0 0
Spain
State/province [524] 0 0
Sabadell
Country [525] 0 0
Spain
State/province [525] 0 0
San Sebastián Guipúzcoa
Country [526] 0 0
Spain
State/province [526] 0 0
Sevilla
Country [527] 0 0
Spain
State/province [527] 0 0
Terrassa
Country [528] 0 0
Spain
State/province [528] 0 0
Valencia
Country [529] 0 0
Spain
State/province [529] 0 0
Valladolid
Country [530] 0 0
Sweden
State/province [530] 0 0
Ljungby
Country [531] 0 0
Sweden
State/province [531] 0 0
Lund
Country [532] 0 0
Sweden
State/province [532] 0 0
Sala
Country [533] 0 0
Sweden
State/province [533] 0 0
Skövde
Country [534] 0 0
Sweden
State/province [534] 0 0
Uppsala
Country [535] 0 0
Switzerland
State/province [535] 0 0
Basel Bs
Country [536] 0 0
Switzerland
State/province [536] 0 0
Bruderholz
Country [537] 0 0
Switzerland
State/province [537] 0 0
Geneve
Country [538] 0 0
Switzerland
State/province [538] 0 0
Zurich
Country [539] 0 0
Taiwan
State/province [539] 0 0
Changhua
Country [540] 0 0
Taiwan
State/province [540] 0 0
Kaohsiung
Country [541] 0 0
Taiwan
State/province [541] 0 0
Taichung
Country [542] 0 0
Taiwan
State/province [542] 0 0
Tainan
Country [543] 0 0
Taiwan
State/province [543] 0 0
Taipei
Country [544] 0 0
Taiwan
State/province [544] 0 0
Tamshui
Country [545] 0 0
Taiwan
State/province [545] 0 0
Tao-Yuan
Country [546] 0 0
Thailand
State/province [546] 0 0
Bangkok Noi
Country [547] 0 0
Thailand
State/province [547] 0 0
Bangkok
Country [548] 0 0
Thailand
State/province [548] 0 0
Chiang Mai
Country [549] 0 0
Thailand
State/province [549] 0 0
Pathumthani
Country [550] 0 0
Thailand
State/province [550] 0 0
Phathumwan
Country [551] 0 0
Thailand
State/province [551] 0 0
Ratchatewi
Country [552] 0 0
Turkey
State/province [552] 0 0
Adana
Country [553] 0 0
Turkey
State/province [553] 0 0
Ankara
Country [554] 0 0
Turkey
State/province [554] 0 0
Antalya
Country [555] 0 0
Turkey
State/province [555] 0 0
Aydin
Country [556] 0 0
Turkey
State/province [556] 0 0
Denizli
Country [557] 0 0
Turkey
State/province [557] 0 0
Diyarbakir
Country [558] 0 0
Turkey
State/province [558] 0 0
Eskisehir
Country [559] 0 0
Turkey
State/province [559] 0 0
Görükle
Country [560] 0 0
Turkey
State/province [560] 0 0
Istanbul
Country [561] 0 0
Turkey
State/province [561] 0 0
Izmir
Country [562] 0 0
Turkey
State/province [562] 0 0
Izmit
Country [563] 0 0
Turkey
State/province [563] 0 0
Kayseri
Country [564] 0 0
Turkey
State/province [564] 0 0
Konya
Country [565] 0 0
Turkey
State/province [565] 0 0
Malatya Nap
Country [566] 0 0
Turkey
State/province [566] 0 0
Mersin
Country [567] 0 0
Turkey
State/province [567] 0 0
Samsun
Country [568] 0 0
Ukraine
State/province [568] 0 0
Cherkassy
Country [569] 0 0
Ukraine
State/province [569] 0 0
Chernigiv
Country [570] 0 0
Ukraine
State/province [570] 0 0
Dnepropetrovsk
Country [571] 0 0
Ukraine
State/province [571] 0 0
Dnipropetrovsk
Country [572] 0 0
Ukraine
State/province [572] 0 0
Donetsk
Country [573] 0 0
Ukraine
State/province [573] 0 0
Ivano-Frankivsk
Country [574] 0 0
Ukraine
State/province [574] 0 0
Kharkiv
Country [575] 0 0
Ukraine
State/province [575] 0 0
Kharkov
Country [576] 0 0
Ukraine
State/province [576] 0 0
Kirovograd
Country [577] 0 0
Ukraine
State/province [577] 0 0
Kyiv
Country [578] 0 0
Ukraine
State/province [578] 0 0
Lugansk
Country [579] 0 0
Ukraine
State/province [579] 0 0
Lviv
Country [580] 0 0
Ukraine
State/province [580] 0 0
O1103 Kyiv
Country [581] 0 0
Ukraine
State/province [581] 0 0
Odesa
Country [582] 0 0
Ukraine
State/province [582] 0 0
Poltava
Country [583] 0 0
Ukraine
State/province [583] 0 0
Simferopil
Country [584] 0 0
Ukraine
State/province [584] 0 0
Sumy
Country [585] 0 0
Ukraine
State/province [585] 0 0
Ternopil
Country [586] 0 0
Ukraine
State/province [586] 0 0
Uzhgorod
Country [587] 0 0
Ukraine
State/province [587] 0 0
Vinnitsya
Country [588] 0 0
Ukraine
State/province [588] 0 0
Vinnytsia
Country [589] 0 0
Ukraine
State/province [589] 0 0
Zaporizhzhya
Country [590] 0 0
Ukraine
State/province [590] 0 0
Zhytomyr
Country [591] 0 0
United Kingdom
State/province [591] 0 0
Aberdeen
Country [592] 0 0
United Kingdom
State/province [592] 0 0
Belfast
Country [593] 0 0
United Kingdom
State/province [593] 0 0
Birmingham
Country [594] 0 0
United Kingdom
State/province [594] 0 0
Bournemouth
Country [595] 0 0
United Kingdom
State/province [595] 0 0
Cambridgeshire
Country [596] 0 0
United Kingdom
State/province [596] 0 0
Chelmsford
Country [597] 0 0
United Kingdom
State/province [597] 0 0
Chesterfield
Country [598] 0 0
United Kingdom
State/province [598] 0 0
Colchester
Country [599] 0 0
United Kingdom
State/province [599] 0 0
Craigavon
Country [600] 0 0
United Kingdom
State/province [600] 0 0
Devon
Country [601] 0 0
United Kingdom
State/province [601] 0 0
Dundee
Country [602] 0 0
United Kingdom
State/province [602] 0 0
Glasgow
Country [603] 0 0
United Kingdom
State/province [603] 0 0
Harrogate
Country [604] 0 0
United Kingdom
State/province [604] 0 0
Hull
Country [605] 0 0
United Kingdom
State/province [605] 0 0
Leicester
Country [606] 0 0
United Kingdom
State/province [606] 0 0
Lincoln
Country [607] 0 0
United Kingdom
State/province [607] 0 0
Liverpool
Country [608] 0 0
United Kingdom
State/province [608] 0 0
London
Country [609] 0 0
United Kingdom
State/province [609] 0 0
Nottingham
Country [610] 0 0
United Kingdom
State/province [610] 0 0
Plymouth
Country [611] 0 0
United Kingdom
State/province [611] 0 0
Romford
Country [612] 0 0
United Kingdom
State/province [612] 0 0
Sheffield
Country [613] 0 0
United Kingdom
State/province [613] 0 0
Stirling
Country [614] 0 0
United Kingdom
State/province [614] 0 0
Stoke On Trent
Country [615] 0 0
United Kingdom
State/province [615] 0 0
York
Country [616] 0 0
Venezuela
State/province [616] 0 0
Caracas
Country [617] 0 0
Venezuela
State/province [617] 0 0
Maracaibo Estado Zulia
Country [618] 0 0
Venezuela
State/province [618] 0 0
Maracay Estado Aragua

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
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
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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/NCT00403767