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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04304508




Registration number
NCT04304508
Ethics application status
Date submitted
8/03/2020
Date registered
11/03/2020

Titles & IDs
Public title
Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
Scientific title
Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Secondary ID [1] 0 0
2019-003431-33
Secondary ID [2] 0 0
19766
Universal Trial Number (UTN)
Trial acronym
PACIFIC-STROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Non-cardioembolic Ischemic Stroke 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 - BAY2433334
Other interventions - BAY2433334 matching placebo

Experimental: BAY2433334 high dose -

Experimental: BAY2433334 medium dose -

Experimental: BAY2433334 low dose -

Placebo comparator: BAY2433334 matching placebo -


Treatment: Drugs: BAY2433334
Tablet, taken orally once a day.

Other interventions: BAY2433334 matching placebo
Tablet, taken orally once a day.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI)
Timepoint [1] 0 0
From baseline up to 26 weeks
Primary outcome [2] 0 0
Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding
Timepoint [2] 0 0
From baseline up to 52 weeks
Secondary outcome [1] 0 0
Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke and Covert Brain Infarcts Detected by MRI, Cardiovascular (CV) Death, Myocardial Infarction (MI) and Systemic Embolism.
Timepoint [1] 0 0
From baseline up to 26 weeks
Secondary outcome [2] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic Stroke
Timepoint [2] 0 0
From baseline up to 52 weeks
Secondary outcome [3] 0 0
Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI
Timepoint [3] 0 0
From baseline up to 26 weeks
Secondary outcome [4] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI
Timepoint [4] 0 0
From baseline up to 52 weeks
Secondary outcome [5] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke
Timepoint [5] 0 0
From baseline up to 52 weeks
Secondary outcome [6] 0 0
Efficacy-Number of Participants With Disabling Stroke (mRS=4)
Timepoint [6] 0 0
From baseline up to 52 weeks
Secondary outcome [7] 0 0
Efficacy-Number of Participants With All-cause Mortality
Timepoint [7] 0 0
From baseline up to 52 weeks
Secondary outcome [8] 0 0
Safety-Number of Participants With All Bleeding
Timepoint [8] 0 0
From baseline up to 52 weeks
Secondary outcome [9] 0 0
Safety-Number of Participants With ISTH Major Bleeding
Timepoint [9] 0 0
From baseline up to 52 weeks
Secondary outcome [10] 0 0
Safety-Number of Participants With ISTH CRNM Bleeding
Timepoint [10] 0 0
From baseline up to 52 weeks
Secondary outcome [11] 0 0
Safety-Number of Participants With ISTH Minor Bleeding
Timepoint [11] 0 0
From baseline up to 52 weeks
Secondary outcome [12] 0 0
Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic)
Timepoint [12] 0 0
From baseline up to 52 weeks

Eligibility
Key inclusion criteria
* Participant must be 45 years of age and older at the time of signing the informed consent
* Non-cardioembolic ischemic stroke with

* persistent signs and symptoms of stroke lasting for = 24 hours OR
* acute brain infarction documented by computed tomography (CT) or MRI AND
* with the intention to be treated with antiplatelet therapy during the study conduct
* Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
* Severity of index event nearest the time of randomization:

* Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) = 7) can be enrolled
* Part B: participants with minor or moderate stroke and NIHSS = 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
* Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
* Ability to conduct an MRI either before randomization or within 72 hours after randomization
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior ischemic stroke within last 30 days of index event
* History of atrial fibrillation or suspicion of cardioembolic source of stroke
* Dysphagia with inability to safely swallow study medication
* Contraindication to perform brain MRI
* Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
* Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.

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 2
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
15/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2022
Sample size
Target
Accrual to date
Final
1808
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [8] 0 0
Eastern Clinical Research Unit - Box Hill - Box Hill
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3052 - Parkville
Recruitment postcode(s) [10] 0 0
3004 - Prahran
Recruitment postcode(s) [11] 0 0
6961 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
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United States of America
State/province [2] 0 0
Minnesota
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United States of America
State/province [3] 0 0
Missouri
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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Austria
State/province [6] 0 0
Burgenland
Country [7] 0 0
Austria
State/province [7] 0 0
Oberösterreich
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Austria
State/province [8] 0 0
Tirol
Country [9] 0 0
Austria
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Salzburg
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Austria
State/province [10] 0 0
Wien
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Belgium
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Limburg
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Belgium
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Liège
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Belgium
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Brasschaat
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Belgium
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Brussel
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Belgium
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Leuven
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Belgium
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Oostende
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Belgium
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Roeselare
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Belgium
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Uccle
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Bulgaria
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Haskovo
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sofia
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Bulgaria
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Varna
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China
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Heilongjiang
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China
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Inner Mongolia
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China
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Jiangsu
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China
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Jilin
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China
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Sichuan
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China
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Shanghai
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China
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Tianjin
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Czechia
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Brno
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Czechia
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Ceske Budejovice
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Czechia
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Hradec Kralove
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Czechia
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Jihlava
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Czechia
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Ostrava Vitkovice
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Czechia
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Ostrava-Poruba
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Czechia
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Pardubice
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Czechia
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Praha 10
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Czechia
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Praha 5-Motol
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Denmark
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Copenhagen
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Denmark
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Glostrup
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Denmark
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Herlev
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Denmark
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Herning
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Denmark
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Hillerød
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Denmark
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Kolding
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Turku
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France
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Besancon
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France
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Bordeaux
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Le Kremlin-bicetre
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France
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Le Mans
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Lille
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France
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Nancy
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France
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PARIS cedex 14
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France
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Paris
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France
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Rennes Cedex
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Toulouse
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Germany
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Thüringen
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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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Kistarcsa
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Hungary
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Pecs
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Szeged
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Zalaegerszeg
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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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Lombardia
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Italy
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Marche
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Italy
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Toscana
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Italy
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Umbria
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Aichi
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Fukuoka
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Hyogo
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Ibaraki
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Kanagawa
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Kyoto
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Osaka
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Tokyo
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Japan
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Gifu
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Kochi
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Kumamoto
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Japan
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Nagano
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Netherlands
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Amsterdam
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Netherlands
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Heerlen
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Netherlands
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Nieuwegein
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Netherlands
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Zwolle
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Poland
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Gdansk
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Poland
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Grodzisk Mazowiecki
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Ostroleka
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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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Russian Federation
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Chelyabinsk
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnodar
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Russian Federation
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Novosibirsk
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Russian Federation
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Sestroretsk
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Russian Federation
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Tomsk
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yekaterinburg
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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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Levoca
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Slovakia
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Liptovsky Mikulas
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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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Spisska Nova Ves
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Slovakia
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Trnava
Country [127] 0 0
Slovakia
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Ziar nad Hronom
Country [128] 0 0
Spain
State/province [128] 0 0
A Coruña
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Spain
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Barcelona
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Spain
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Madrid
Country [131] 0 0
Spain
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Albacete
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Spain
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Lleida
Country [133] 0 0
Spain
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Sevilla
Country [134] 0 0
Spain
State/province [134] 0 0
Valencia
Country [135] 0 0
Spain
State/province [135] 0 0
Valladolid
Country [136] 0 0
Sweden
State/province [136] 0 0
Lund
Country [137] 0 0
Sweden
State/province [137] 0 0
Stockholm
Country [138] 0 0
Sweden
State/province [138] 0 0
Umeå
Country [139] 0 0
Switzerland
State/province [139] 0 0
Basel-Stadt
Country [140] 0 0
Switzerland
State/province [140] 0 0
Bern
Country [141] 0 0
Switzerland
State/province [141] 0 0
Sankt Gallen
Country [142] 0 0
Switzerland
State/province [142] 0 0
Baden
Country [143] 0 0
Switzerland
State/province [143] 0 0
Lugano
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Cheshire
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Merseyside
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Tyne And Wear
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cambridge
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Coventry
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Glasgow
Country [150] 0 0
United Kingdom
State/province [150] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
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
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04304508