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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00571649




Registration number
NCT00571649
Ethics application status
Date submitted
11/12/2007
Date registered
12/12/2007
Date last updated
15/09/2016

Titles & IDs
Public title
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Scientific title
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Secondary ID [1] 0 0
2007-004614-14
Secondary ID [2] 0 0
12839
Universal Trial Number (UTN)
Trial acronym
MAGELLAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Enoxaparin placebo

Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Active comparator: Enoxaparin - Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

Treatment: Drugs: Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Treatment: Drugs: Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Treatment: Drugs: Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
Timepoint [1] 0 0
Up to Day 35 + 6 days
Primary outcome [2] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [1] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
Timepoint [1] 0 0
Up to Day 35 + 6 days
Secondary outcome [2] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [3] 0 0
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
Timepoint [3] 0 0
Up to Day 10 + 5 days
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
Timepoint [4] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [5] 0 0
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
Timepoint [5] 0 0
Up to Day 35 + 6 days
Secondary outcome [6] 0 0
Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days
Timepoint [6] 0 0
Up to Day 10 + 5 days
Secondary outcome [7] 0 0
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Timepoint [7] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [8] 0 0
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
Timepoint [8] 0 0
Up to Day 35 + 6 days
Secondary outcome [9] 0 0
Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Timepoint [9] 0 0
Up to Day 10 + 5 days
Secondary outcome [10] 0 0
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Timepoint [10] 0 0
Up to Day 90 + 7 days
Secondary outcome [11] 0 0
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)
Timepoint [11] 0 0
Up to Day 35 + 6 days
Secondary outcome [12] 0 0
Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)
Timepoint [12] 0 0
Up to Day 10 + 5 days

Eligibility
Key inclusion criteria
* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

* Heart failure, New York Heart Association (NYHA) class III or IV
* Active cancer
* Acute ischemic stroke
* Acute infectious and inflammatory diseases, including acute rheumatic diseases
* Acute respiratory insufficiency
* Additional risk factor for VTE, including reduced mobility
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study

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
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
8101
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Lismore
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Auchenflower
Recruitment hospital [6] 0 0
- Brisbane
Recruitment hospital [7] 0 0
- Redcliffe
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- Southport
Recruitment hospital [9] 0 0
- Woollongabba
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- Adelaide
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- Launceston
Recruitment hospital [12] 0 0
- Box Hill
Recruitment hospital [13] 0 0
- Clayton
Recruitment hospital [14] 0 0
- Melbourne
Recruitment hospital [15] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2229 - Sydney
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4066 - Auchenflower
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4066 - Brisbane
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4101 - Brisbane
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4020 - Redcliffe
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4215 - Southport
Recruitment postcode(s) [10] 0 0
4102 - Woollongabba
Recruitment postcode(s) [11] 0 0
5042 - Adelaide
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3168 - Clayton
Recruitment postcode(s) [15] 0 0
3135 - Melbourne
Recruitment postcode(s) [16] 0 0
3144 - Melbourne
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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Mumbai
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India
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Noida
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Indonesia
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Jakarta
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Indonesia
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Surabaya
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Israel
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Afula
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Israel
State/province [190] 0 0
Ashkelon
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Israel
State/province [191] 0 0
Haifa
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Israel
State/province [192] 0 0
Holon
Country [193] 0 0
Israel
State/province [193] 0 0
Kfar Saba
Country [194] 0 0
Israel
State/province [194] 0 0
Rehovot
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Israel
State/province [195] 0 0
Tel Aviv
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Israel
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Zefat
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Italy
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Bari
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Molise
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Italy
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Parma
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Italy
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Sicilia
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Italy
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Trentino-Alto Adige
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Italy
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Umbria
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Italy
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Verbano-Cusio-Ossola
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Italy
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Bergamo
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Italy
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Latina
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Italy
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Reggio Calabria
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Italy
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Vicenza
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
State/province [217] 0 0
Hiroshima
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Japan
State/province [218] 0 0
Hokkaido
Country [219] 0 0
Japan
State/province [219] 0 0
Hyogo
Country [220] 0 0
Japan
State/province [220] 0 0
Ishikawa
Country [221] 0 0
Japan
State/province [221] 0 0
Iwate
Country [222] 0 0
Japan
State/province [222] 0 0
Kanagawa
Country [223] 0 0
Japan
State/province [223] 0 0
Kochi
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Japan
State/province [224] 0 0
Mie
Country [225] 0 0
Japan
State/province [225] 0 0
Niigata
Country [226] 0 0
Japan
State/province [226] 0 0
Okinawa
Country [227] 0 0
Japan
State/province [227] 0 0
Osaka
Country [228] 0 0
Japan
State/province [228] 0 0
Shiga
Country [229] 0 0
Japan
State/province [229] 0 0
Shizuoka
Country [230] 0 0
Japan
State/province [230] 0 0
Tokyo
Country [231] 0 0
Japan
State/province [231] 0 0
Yamaguchi
Country [232] 0 0
Japan
State/province [232] 0 0
Fukui
Country [233] 0 0
Japan
State/province [233] 0 0
Ibaraki
Country [234] 0 0
Japan
State/province [234] 0 0
Kumamoto
Country [235] 0 0
Japan
State/province [235] 0 0
Kyoto
Country [236] 0 0
Korea, Republic of
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Korea
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jeollanam-do
Country [240] 0 0
Korea, Republic of
State/province [240] 0 0
Seoul
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Latvia
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Daugavpils
Country [242] 0 0
Latvia
State/province [242] 0 0
Liepaja
Country [243] 0 0
Latvia
State/province [243] 0 0
Riga
Country [244] 0 0
Latvia
State/province [244] 0 0
Valmiera
Country [245] 0 0
Latvia
State/province [245] 0 0
Ventspils
Country [246] 0 0
Lithuania
State/province [246] 0 0
Kaunas
Country [247] 0 0
Lithuania
State/province [247] 0 0
Klaipeda
Country [248] 0 0
Lithuania
State/province [248] 0 0
Siauliai
Country [249] 0 0
Lithuania
State/province [249] 0 0
Utena
Country [250] 0 0
Lithuania
State/province [250] 0 0
Vilnius
Country [251] 0 0
Luxembourg
State/province [251] 0 0
Kirchberg
Country [252] 0 0
Luxembourg
State/province [252] 0 0
Luxembourg
Country [253] 0 0
Luxembourg
State/province [253] 0 0
Niederkorn
Country [254] 0 0
Malaysia
State/province [254] 0 0
Kuala Lumpur
Country [255] 0 0
Malaysia
State/province [255] 0 0
Negeri Sembilan,
Country [256] 0 0
Malaysia
State/province [256] 0 0
Sarawak
Country [257] 0 0
Mexico
State/province [257] 0 0
Chiapas
Country [258] 0 0
Mexico
State/province [258] 0 0
Coahuila
Country [259] 0 0
Mexico
State/province [259] 0 0
Distrito Federal
Country [260] 0 0
Mexico
State/province [260] 0 0
Jalisco
Country [261] 0 0
Mexico
State/province [261] 0 0
Michoacán
Country [262] 0 0
Mexico
State/province [262] 0 0
México
Country [263] 0 0
Mexico
State/province [263] 0 0
Nuevo Leon
Country [264] 0 0
Mexico
State/province [264] 0 0
Sonora
Country [265] 0 0
Mexico
State/province [265] 0 0
Yucatán
Country [266] 0 0
Mexico
State/province [266] 0 0
Aguascalientes
Country [267] 0 0
Mexico
State/province [267] 0 0
Chihuahua
Country [268] 0 0
Mexico
State/province [268] 0 0
Puebla
Country [269] 0 0
Mexico
State/province [269] 0 0
Zacatecas
Country [270] 0 0
Netherlands
State/province [270] 0 0
Amersfoort
Country [271] 0 0
Netherlands
State/province [271] 0 0
Amsterdam
Country [272] 0 0
Netherlands
State/province [272] 0 0
Enschede
Country [273] 0 0
Netherlands
State/province [273] 0 0
Heerlen
Country [274] 0 0
Netherlands
State/province [274] 0 0
Maastricht
Country [275] 0 0
Netherlands
State/province [275] 0 0
Nieuwegein
Country [276] 0 0
Netherlands
State/province [276] 0 0
Rotterdam
Country [277] 0 0
Netherlands
State/province [277] 0 0
Sittard
Country [278] 0 0
Netherlands
State/province [278] 0 0
Utrecht
Country [279] 0 0
New Zealand
State/province [279] 0 0
Auckland
Country [280] 0 0
New Zealand
State/province [280] 0 0
Christchurch
Country [281] 0 0
Norway
State/province [281] 0 0
Fredrikstad
Country [282] 0 0
Norway
State/province [282] 0 0
Gjøvik
Country [283] 0 0
Norway
State/province [283] 0 0
Hamar
Country [284] 0 0
Norway
State/province [284] 0 0
Oslo
Country [285] 0 0
Pakistan
State/province [285] 0 0
Karachi
Country [286] 0 0
Pakistan
State/province [286] 0 0
Lahore
Country [287] 0 0
Peru
State/province [287] 0 0
Callao
Country [288] 0 0
Peru
State/province [288] 0 0
Lima Cercado
Country [289] 0 0
Peru
State/province [289] 0 0
Lima
Country [290] 0 0
Poland
State/province [290] 0 0
Bialystok
Country [291] 0 0
Poland
State/province [291] 0 0
Bydgoszcz
Country [292] 0 0
Poland
State/province [292] 0 0
Krakow
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Poland
State/province [293] 0 0
Lublin
Country [294] 0 0
Poland
State/province [294] 0 0
Olsztyn
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Poland
State/province [295] 0 0
Piotrkow Trybunalski
Country [296] 0 0
Poland
State/province [296] 0 0
Siedlce
Country [297] 0 0
Poland
State/province [297] 0 0
Starogard Gdanski
Country [298] 0 0
Poland
State/province [298] 0 0
Szczecin
Country [299] 0 0
Poland
State/province [299] 0 0
Tarnów
Country [300] 0 0
Poland
State/province [300] 0 0
Warszawa
Country [301] 0 0
Poland
State/province [301] 0 0
Wloclawek
Country [302] 0 0
Portugal
State/province [302] 0 0
Coimbra
Country [303] 0 0
Portugal
State/province [303] 0 0
Amadora
Country [304] 0 0
Portugal
State/province [304] 0 0
Cascais
Country [305] 0 0
Portugal
State/province [305] 0 0
Lisboa
Country [306] 0 0
Portugal
State/province [306] 0 0
Matosinhos
Country [307] 0 0
Portugal
State/province [307] 0 0
Porto
Country [308] 0 0
Portugal
State/province [308] 0 0
Santarém
Country [309] 0 0
Portugal
State/province [309] 0 0
Viana do Castelo
Country [310] 0 0
Romania
State/province [310] 0 0
Bucharest
Country [311] 0 0
Romania
State/province [311] 0 0
Constanta
Country [312] 0 0
Romania
State/province [312] 0 0
Suceava
Country [313] 0 0
Russian Federation
State/province [313] 0 0
Moscow
Country [314] 0 0
Russian Federation
State/province [314] 0 0
Nizhny Novgorod
Country [315] 0 0
Russian Federation
State/province [315] 0 0
Yaroslavl
Country [316] 0 0
Singapore
State/province [316] 0 0
Singapore
Country [317] 0 0
Slovakia
State/province [317] 0 0
Bratislava
Country [318] 0 0
Slovakia
State/province [318] 0 0
Lucenec
Country [319] 0 0
Slovakia
State/province [319] 0 0
Martin
Country [320] 0 0
Slovakia
State/province [320] 0 0
Zilina
Country [321] 0 0
Slovenia
State/province [321] 0 0
Golnik
Country [322] 0 0
Slovenia
State/province [322] 0 0
Ljubljana
Country [323] 0 0
Slovenia
State/province [323] 0 0
Novo mesto
Country [324] 0 0
South Africa
State/province [324] 0 0
Freestate
Country [325] 0 0
South Africa
State/province [325] 0 0
Gauteng
Country [326] 0 0
South Africa
State/province [326] 0 0
Western Cape
Country [327] 0 0
South Africa
State/province [327] 0 0
Sandton, Gauteng
Country [328] 0 0
Spain
State/province [328] 0 0
Barcelona
Country [329] 0 0
Spain
State/province [329] 0 0
Córdoba
Country [330] 0 0
Spain
State/province [330] 0 0
Girona
Country [331] 0 0
Spain
State/province [331] 0 0
Murcia
Country [332] 0 0
Spain
State/province [332] 0 0
Málaga
Country [333] 0 0
Spain
State/province [333] 0 0
Pontevedra
Country [334] 0 0
Spain
State/province [334] 0 0
Cuenca
Country [335] 0 0
Spain
State/province [335] 0 0
Zaragoza
Country [336] 0 0
Sweden
State/province [336] 0 0
Borås
Country [337] 0 0
Sweden
State/province [337] 0 0
Hässleholm
Country [338] 0 0
Sweden
State/province [338] 0 0
Karlshamn
Country [339] 0 0
Sweden
State/province [339] 0 0
Kristianstad
Country [340] 0 0
Sweden
State/province [340] 0 0
Lund
Country [341] 0 0
Sweden
State/province [341] 0 0
Malmö
Country [342] 0 0
Sweden
State/province [342] 0 0
Skövde
Country [343] 0 0
Sweden
State/province [343] 0 0
Stockholm
Country [344] 0 0
Sweden
State/province [344] 0 0
Sundsvall
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Sweden
State/province [345] 0 0
Umeå
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Sweden
State/province [346] 0 0
Visby
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Switzerland
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Basel-Landschaft
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Switzerland
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Basel-Stadt
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Switzerland
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Bern
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Switzerland
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Baden
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Switzerland
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Genève
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Switzerland
State/province [352] 0 0
Luzern
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Switzerland
State/province [353] 0 0
Zürich
Country [354] 0 0
Taiwan
State/province [354] 0 0
Kaohsiung
Country [355] 0 0
Taiwan
State/province [355] 0 0
Tainan
Country [356] 0 0
Taiwan
State/province [356] 0 0
Taipei
Country [357] 0 0
Thailand
State/province [357] 0 0
Bangkok
Country [358] 0 0
Thailand
State/province [358] 0 0
Chiangmai
Country [359] 0 0
Turkey
State/province [359] 0 0
Istanbul
Country [360] 0 0
Turkey
State/province [360] 0 0
Izmir
Country [361] 0 0
Ukraine
State/province [361] 0 0
Donetsk
Country [362] 0 0
Ukraine
State/province [362] 0 0
Ivano-Frankivsk
Country [363] 0 0
Ukraine
State/province [363] 0 0
Kharkiv
Country [364] 0 0
Ukraine
State/province [364] 0 0
Kiev
Country [365] 0 0
Ukraine
State/province [365] 0 0
Kyiv
Country [366] 0 0
Ukraine
State/province [366] 0 0
Lviv
Country [367] 0 0
Ukraine
State/province [367] 0 0
Odessa
Country [368] 0 0
Ukraine
State/province [368] 0 0
Simferopol
Country [369] 0 0
United Kingdom
State/province [369] 0 0
Cleveland
Country [370] 0 0
United Kingdom
State/province [370] 0 0
Dumfries and Galloway
Country [371] 0 0
United Kingdom
State/province [371] 0 0
Merseyside
Country [372] 0 0
United Kingdom
State/province [372] 0 0
South Yorkshire
Country [373] 0 0
United Kingdom
State/province [373] 0 0
Stratchclyde
Country [374] 0 0
United Kingdom
State/province [374] 0 0
Tyne and Wear
Country [375] 0 0
United Kingdom
State/province [375] 0 0
West Yorkshire
Country [376] 0 0
United Kingdom
State/province [376] 0 0
London
Country [377] 0 0
United Kingdom
State/province [377] 0 0
Nottingham

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


Results are available at https://clinicaltrials.gov/study/NCT00571649