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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05686070




Registration number
NCT05686070
Ethics application status
Date submitted
6/01/2023
Date registered
17/01/2023

Titles & IDs
Public title
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
Scientific title
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA
Secondary ID [1] 0 0
2023-503793-20-00
Secondary ID [2] 0 0
20604
Universal Trial Number (UTN)
Trial acronym
OCEANIC-STROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Ischemic Stroke 0 0
Acute Non-cardioembolic Ischemic Stroke 0 0
High-risk Transient Ischemic Attack 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Asundexian (BAY2433334)
Treatment: Drugs - Placebo

Experimental: Asundexian - Participants will receive asundexian.

Placebo comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: Asundexian (BAY2433334)
Once daily, oral

Treatment: Drugs: Placebo
Placebo to asundexian, once daily, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of ischemic stroke
Timepoint [1] 0 0
Up to 31 months
Primary outcome [2] 0 0
Time to first occurrence of ISTH major bleeding
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Time to first occurrence of all strokes (ischemic and hemorrhagic)
Timepoint [1] 0 0
Up to 31 months
Secondary outcome [2] 0 0
Time to first occurrence of composite of CV death, MI or stroke
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [3] 0 0
Time to first occurrence of composite of all-cause mortality, MI or stroke
Timepoint [3] 0 0
Up to 31 months
Secondary outcome [4] 0 0
Time to first occurrence of disabling stroke (mRS =3 at 90 days)
Timepoint [4] 0 0
Up to 31 months
Secondary outcome [5] 0 0
Time to first occurrence of all-cause mortality
Timepoint [5] 0 0
Up to 31 months
Secondary outcome [6] 0 0
Time to first occurrence of transient ischemic attack (TIA)
Timepoint [6] 0 0
Up to 31 months
Secondary outcome [7] 0 0
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
Timepoint [7] 0 0
Up to 31 months
Secondary outcome [8] 0 0
Time to first occurrence of ISTH clinically relevant non-major bleeding
Timepoint [8] 0 0
Up to 31 months
Secondary outcome [9] 0 0
Time to first occurrence of symptomatic intracranial hemorrhage
Timepoint [9] 0 0
Up to 31 months
Secondary outcome [10] 0 0
Time to first occurrence of hemorrhagic stroke
Timepoint [10] 0 0
Up to 31 months
Secondary outcome [11] 0 0
Time to first occurrence of fatal bleeding
Timepoint [11] 0 0
Up to 31 months
Secondary outcome [12] 0 0
Time to first occurrence of minor bleeding
Timepoint [12] 0 0
Up to 31 months
Secondary outcome [13] 0 0
Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
Timepoint [13] 0 0
Up to 31 months
Secondary outcome [14] 0 0
Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
Timepoint [14] 0 0
Up to 31 months
Secondary outcome [15] 0 0
Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
Timepoint [15] 0 0
Up to 31 months
Secondary outcome [16] 0 0
Time to first occurrence of ischemic stroke in the first 90 days
Timepoint [16] 0 0
Up to 31 months

Eligibility
Key inclusion criteria
* Participants must be = 18 years of age
* Acute non-cardioembolic stroke or high-risk TIA
* Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Ischemic stroke = 7 days before the index event
* Index stroke following procedures or strokes due to other rare causes
* History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or other cardioembolic source of stroke requiring anticoagulation

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 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
12300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [3] 0 0
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department - Liverpool
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Newtown
Recruitment hospital [6] 0 0
Prince of Wales Hospital NSW - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 0 0
Nepean Hospital - Sydney
Recruitment hospital [9] 0 0
Westmead Hospital - Westmead
Recruitment hospital [10] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [11] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [12] 0 0
Princess Alexandra Hospital Australia - Brisbane
Recruitment hospital [13] 0 0
Redcliffe District Hospital - Redcliffe
Recruitment hospital [14] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [15] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [17] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [18] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [19] 0 0
Eastern Health Box Hill Hospital - Box Hill
Recruitment hospital [20] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [21] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [22] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [23] 0 0
Western Health Neuroscience Research Unit - St Albans
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Fiona Stanley Hospital - Murdoch
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Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2148 - Blacktown
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2170 - Liverpool
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2305 - New Lambton
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2042 - Newtown
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2031 - Randwick
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2065 - St Leonards
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2751 - Sydney
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2145 - Westmead
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4575 - Birtinya
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4029 - Brisbane
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4102 - Brisbane
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4020 - Redcliffe
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4215 - Southport
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5000 - Adelaide
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5112 - Elizabeth Vale
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7250 - Launceston
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3350 - Ballarat
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3128 - Box Hill
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3168 - Clayton
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3004 - Melbourne
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3050 - Parkville
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3021 - St Albans
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6961 - Murdoch
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6009 - Nedlands
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Greece
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Athens
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Greece
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Greece
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Heraklion
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Greece
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Greece
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Larissa
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Greece
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Patra
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Pilea Chortiatis
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Hungary
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Baja
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Kistarcsa
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Hungary
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Kisvarda
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Hungary
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Nagykanizsa
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Hungary
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Nyiregyhaza
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Hungary
State/province [203] 0 0
Pecs
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Hungary
State/province [204] 0 0
Sopron
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Hungary
State/province [205] 0 0
Szeged
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Hungary
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Zalaegerszeg
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India
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Andhra Pradesh
Country [208] 0 0
India
State/province [208] 0 0
Gujarat
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India
State/province [209] 0 0
Karnataka
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India
State/province [210] 0 0
Kerala
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India
State/province [211] 0 0
Telangana
Country [212] 0 0
India
State/province [212] 0 0
Chandigarh
Country [213] 0 0
India
State/province [213] 0 0
Coimbatore
Country [214] 0 0
India
State/province [214] 0 0
Gurgaon
Country [215] 0 0
India
State/province [215] 0 0
Guwahati
Country [216] 0 0
India
State/province [216] 0 0
Hyderabad
Country [217] 0 0
India
State/province [217] 0 0
Jaipur
Country [218] 0 0
India
State/province [218] 0 0
Karamsad
Country [219] 0 0
India
State/province [219] 0 0
Kolkata
Country [220] 0 0
India
State/province [220] 0 0
Ludhiana
Country [221] 0 0
India
State/province [221] 0 0
Nagpur
Country [222] 0 0
India
State/province [222] 0 0
New Delhi
Country [223] 0 0
India
State/province [223] 0 0
Pune
Country [224] 0 0
India
State/province [224] 0 0
Thiruvananthapuram
Country [225] 0 0
India
State/province [225] 0 0
Vellore
Country [226] 0 0
Israel
State/province [226] 0 0
Ashdod
Country [227] 0 0
Israel
State/province [227] 0 0
Ashkelon
Country [228] 0 0
Israel
State/province [228] 0 0
Beer Sheva
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Israel
State/province [229] 0 0
Hadera
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Israel
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Haifa
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Israel
State/province [231] 0 0
Holon
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Israel
State/province [232] 0 0
Jerusalem
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Israel
State/province [233] 0 0
Kfar Saba
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Israel
State/province [234] 0 0
Petach Tikva
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Israel
State/province [235] 0 0
Ramat Gan
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Israel
State/province [236] 0 0
Tel Aviv
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Israel
State/province [237] 0 0
Zefat
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Israel
State/province [238] 0 0
Zerifin
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Italy
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Abruzzo
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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
State/province [242] 0 0
Friuli-Venezia Giulia
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Italy
State/province [243] 0 0
Lazio
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Italy
State/province [244] 0 0
Liguria
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Italy
State/province [245] 0 0
Lombardia
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Italy
State/province [246] 0 0
Puglia
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Italy
State/province [247] 0 0
Sicilia
Country [248] 0 0
Italy
State/province [248] 0 0
Toscana
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Italy
State/province [249] 0 0
Umbria
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Italy
State/province [250] 0 0
Veneto
Country [251] 0 0
Italy
State/province [251] 0 0
Ancona
Country [252] 0 0
Italy
State/province [252] 0 0
Torino
Country [253] 0 0
Japan
State/province [253] 0 0
Aichi
Country [254] 0 0
Japan
State/province [254] 0 0
Chiba
Country [255] 0 0
Japan
State/province [255] 0 0
Fukuoka
Country [256] 0 0
Japan
State/province [256] 0 0
Fukushima
Country [257] 0 0
Japan
State/province [257] 0 0
Gifu
Country [258] 0 0
Japan
State/province [258] 0 0
Gunma
Country [259] 0 0
Japan
State/province [259] 0 0
Hiroshima
Country [260] 0 0
Japan
State/province [260] 0 0
Hokkaido
Country [261] 0 0
Japan
State/province [261] 0 0
Hyogo
Country [262] 0 0
Japan
State/province [262] 0 0
Ibaraki
Country [263] 0 0
Japan
State/province [263] 0 0
Kagawa
Country [264] 0 0
Japan
State/province [264] 0 0
Kanagawa
Country [265] 0 0
Japan
State/province [265] 0 0
Kyoto
Country [266] 0 0
Japan
State/province [266] 0 0
Miyagi
Country [267] 0 0
Japan
State/province [267] 0 0
Nagano-ken
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Japan
State/province [268] 0 0
Nagano
Country [269] 0 0
Japan
State/province [269] 0 0
Oita
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Japan
State/province [270] 0 0
Okayama
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Japan
State/province [271] 0 0
Osaka
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Japan
State/province [272] 0 0
Saga
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Japan
State/province [273] 0 0
Saitama
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Japan
State/province [274] 0 0
Shizuoka
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Japan
State/province [275] 0 0
Tokyo
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Japan
State/province [276] 0 0
Wakayama
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Japan
State/province [277] 0 0
Yamaguchi
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Japan
State/province [278] 0 0
Yamanashi
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Japan
State/province [279] 0 0
Kagoshima
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Japan
State/province [280] 0 0
Kochi
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Japan
State/province [281] 0 0
Kumamoto
Country [282] 0 0
Kazakhstan
State/province [282] 0 0
Aktobe
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Kazakhstan
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Kazakhstan
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Shymkent
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Korea, Republic of
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Chungcheongbugdo
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Korea, Republic of
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Dong-gu, Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul,
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Korea, Republic of
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Rezekne
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Riga
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Lithuania
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Kaunas
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Lithuania
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Siauliai
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Lithuania
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Kelantan
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Malaysia
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Kota Kinabalu
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Den Haag
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Netherlands
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Heerlen
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Zwolle
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Norway
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Norway
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Grålum
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Norway
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Kristiansand
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Norway
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Lørenskog
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Norway
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Molde
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Norway
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Oslo
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Norway
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Trondheim
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Norway
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Ålesund
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Poland
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Bialystok
Country [332] 0 0
Poland
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Bydgoszcz
Country [333] 0 0
Poland
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Gdansk
Country [334] 0 0
Poland
State/province [334] 0 0
Grodzisk Mazowiecki
Country [335] 0 0
Poland
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Katowice
Country [336] 0 0
Poland
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Krakow
Country [337] 0 0
Poland
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Lodz
Country [338] 0 0
Poland
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Lublin
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Poland
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Opole
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Poland
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Szczecin
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Poland
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Warszawa
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Setúbal
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Portugal
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Coimbra
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Portugal
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Faro
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Portugal
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Leiria
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Sibiu
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Romania
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Suceava
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Romania
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Targu Mures
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Romania
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Timisoara
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Slovakia
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Bratislava
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Slovakia
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Dolny Kubin
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Slovakia
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Komarno
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Slovakia
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Levoca
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Slovakia
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Liptovsky Mikulas
Country [362] 0 0
Slovakia
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Lucenec
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Slovakia
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Martin
Country [364] 0 0
Slovakia
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Nitra
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Slovakia
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Presov
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Slovakia
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Rimavska Sobota
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Slovakia
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Skalica
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Slovakia
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Slovakia
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Trnava
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Slovakia
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Vranou Nad Toplou
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Slovakia
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Ziar nad Hronom
Country [372] 0 0
Spain
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A Coruña
Country [373] 0 0
Spain
State/province [373] 0 0
Barcelona
Country [374] 0 0
Spain
State/province [374] 0 0
Madrid
Country [375] 0 0
Spain
State/province [375] 0 0
Pontevedra
Country [376] 0 0
Spain
State/province [376] 0 0
Vizcaya
Country [377] 0 0
Spain
State/province [377] 0 0
Albacete
Country [378] 0 0
Spain
State/province [378] 0 0
Girona
Country [379] 0 0
Spain
State/province [379] 0 0
León
Country [380] 0 0
Spain
State/province [380] 0 0
Lleida
Country [381] 0 0
Spain
State/province [381] 0 0
Murcia
Country [382] 0 0
Spain
State/province [382] 0 0
Sevilla
Country [383] 0 0
Spain
State/province [383] 0 0
Tarragona
Country [384] 0 0
Spain
State/province [384] 0 0
Valencia
Country [385] 0 0
Spain
State/province [385] 0 0
Valladolid
Country [386] 0 0
Spain
State/province [386] 0 0
Zaragoza
Country [387] 0 0
Sweden
State/province [387] 0 0
Danderyd
Country [388] 0 0
Sweden
State/province [388] 0 0
Göteborg
Country [389] 0 0
Sweden
State/province [389] 0 0
Hässleholm
Country [390] 0 0
Sweden
State/province [390] 0 0
Lund
Country [391] 0 0
Sweden
State/province [391] 0 0
Stockholm
Country [392] 0 0
Sweden
State/province [392] 0 0
Uppsala
Country [393] 0 0
Sweden
State/province [393] 0 0
Östersund
Country [394] 0 0
Switzerland
State/province [394] 0 0
Aargau
Country [395] 0 0
Switzerland
State/province [395] 0 0
Basel-Stadt
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Switzerland
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Genève
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Switzerland
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Sankt Gallen
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Switzerland
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Ticino
Country [399] 0 0
Switzerland
State/province [399] 0 0
Vaud
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Switzerland
State/province [400] 0 0
Bern
Country [401] 0 0
Switzerland
State/province [401] 0 0
Villars sur Glâne
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Switzerland
State/province [402] 0 0
Zürich
Country [403] 0 0
Taiwan
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Hsinchu
Country [404] 0 0
Taiwan
State/province [404] 0 0
Kaohsiung
Country [405] 0 0
Taiwan
State/province [405] 0 0
Taipei
Country [406] 0 0
Taiwan
State/province [406] 0 0
Changhua
Country [407] 0 0
Taiwan
State/province [407] 0 0
Kaohsiung City
Country [408] 0 0
Taiwan
State/province [408] 0 0
Keelung
Country [409] 0 0
Taiwan
State/province [409] 0 0
New Taipei City
Country [410] 0 0
Taiwan
State/province [410] 0 0
Taichung
Country [411] 0 0
Taiwan
State/province [411] 0 0
Tainan
Country [412] 0 0
Taiwan
State/province [412] 0 0
Taipei City
Country [413] 0 0
Taiwan
State/province [413] 0 0
Taoyuan
Country [414] 0 0
Turkey
State/province [414] 0 0
Ankara
Country [415] 0 0
Turkey
State/province [415] 0 0
Antalya
Country [416] 0 0
Turkey
State/province [416] 0 0
Elazig
Country [417] 0 0
Turkey
State/province [417] 0 0
Eskisehir
Country [418] 0 0
Turkey
State/province [418] 0 0
Istanbul
Country [419] 0 0
Turkey
State/province [419] 0 0
Izmir
Country [420] 0 0
Turkey
State/province [420] 0 0
Kayseri
Country [421] 0 0
Turkey
State/province [421] 0 0
Konya
Country [422] 0 0
Turkey
State/province [422] 0 0
Samsun
Country [423] 0 0
Turkey
State/province [423] 0 0
Sivas
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Hampshire
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Kent
Country [426] 0 0
United Kingdom
State/province [426] 0 0
London
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Manchester
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Staffordshire
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Tyne And Wear
Country [430] 0 0
United Kingdom
State/province [430] 0 0
West Yorkshire
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Derby
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Edinburgh
Country [433] 0 0
United Kingdom
State/province [433] 0 0
Exeter
Country [434] 0 0
United Kingdom
State/province [434] 0 0
Glasgow
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Liverpool
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


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 not provided in https://clinicaltrials.gov/study/NCT05686070