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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02545049




Registration number
NCT02545049
Ethics application status
Date submitted
2/09/2015
Date registered
9/09/2015

Titles & IDs
Public title
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
Secondary ID [1] 0 0
2015-000950-39
Secondary ID [2] 0 0
17530
Universal Trial Number (UTN)
Trial acronym
FIGARO-DKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo

Experimental: BAY94-8862 - Finerenone tablet

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.

Treatment: Drugs: Placebo
Matching placebo to be taken orally, once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.
Timepoint [1] 0 0
From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
Secondary outcome [1] 0 0
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR =40% From Baseline Over at Least 4 Weeks, or Renal Death.
Timepoint [1] 0 0
From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
Secondary outcome [2] 0 0
All-cause Hospitalization
Timepoint [2] 0 0
From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months
Secondary outcome [3] 0 0
All-cause Mortality
Timepoint [3] 0 0
From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months
Secondary outcome [4] 0 0
Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4
Timepoint [4] 0 0
From baseline up until Month 4
Secondary outcome [5] 0 0
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of =57% From Baseline Over at Least 4 Weeks, or Renal Death
Timepoint [5] 0 0
From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months

Eligibility
Key inclusion criteria
* Men or women =18 years of age
* Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
* Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
* Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
* Serum potassium <=4.8 mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) =170 mmHg or mean sitting diastolic blood pressure(DBP) =110 mmHg at run in visit, or mean sitting SBP =160 mmHg or mean sitting DBP =100 mmHg at screening)
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]
* Dialysis for acute renal failure within 12 weeks of Run-in visit
* Renal allograft in place or scheduled kidney transplant within next 12 months
* Glycated hemoglobin (HbA1c) >12%

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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ACT,NSW,QLD,SA,VIC
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- Garran
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- Gosford
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- Kanwal
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- Liverpool
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- New Lambton Heights
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- Wollongong
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- Adelaide
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- Fitzroy
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- Heidelberg
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- Melbourne
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- Prahran
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- Reservoir
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- Richmond
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- St. Albans
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- Elizabeth Vale
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2605 - Garran
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2250 - Gosford
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2500 - Wollongong
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4064 - Brisbane
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5000 - Adelaide
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3065 - Fitzroy
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3121 - Richmond
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5112 - Elizabeth Vale
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State/province [208] 0 0
Kistarcsa
Country [209] 0 0
Hungary
State/province [209] 0 0
Nyiregyhaza
Country [210] 0 0
Hungary
State/province [210] 0 0
Papa
Country [211] 0 0
Hungary
State/province [211] 0 0
Siofok
Country [212] 0 0
Hungary
State/province [212] 0 0
Szeged
Country [213] 0 0
Hungary
State/province [213] 0 0
Szekesfehervar
Country [214] 0 0
Hungary
State/province [214] 0 0
Szentes
Country [215] 0 0
Hungary
State/province [215] 0 0
Szombathely
Country [216] 0 0
Ireland
State/province [216] 0 0
Cork
Country [217] 0 0
Ireland
State/province [217] 0 0
Dublin
Country [218] 0 0
Ireland
State/province [218] 0 0
Galway
Country [219] 0 0
Israel
State/province [219] 0 0
Afula
Country [220] 0 0
Israel
State/province [220] 0 0
Ashkelon
Country [221] 0 0
Israel
State/province [221] 0 0
Beer Sheva
Country [222] 0 0
Israel
State/province [222] 0 0
Haifa
Country [223] 0 0
Israel
State/province [223] 0 0
Holon
Country [224] 0 0
Israel
State/province [224] 0 0
Jerusalem
Country [225] 0 0
Israel
State/province [225] 0 0
Kfar Saba
Country [226] 0 0
Israel
State/province [226] 0 0
Nahariya
Country [227] 0 0
Israel
State/province [227] 0 0
Nazareth
Country [228] 0 0
Israel
State/province [228] 0 0
Ramat Gan
Country [229] 0 0
Israel
State/province [229] 0 0
Rehovot
Country [230] 0 0
Israel
State/province [230] 0 0
Sakhnin
Country [231] 0 0
Israel
State/province [231] 0 0
Tel Aviv
Country [232] 0 0
Israel
State/province [232] 0 0
Tiberias
Country [233] 0 0
Israel
State/province [233] 0 0
Zefat
Country [234] 0 0
Israel
State/province [234] 0 0
Zerifin
Country [235] 0 0
Italy
State/province [235] 0 0
Campania
Country [236] 0 0
Italy
State/province [236] 0 0
Emilia-Romagna
Country [237] 0 0
Italy
State/province [237] 0 0
Liguria
Country [238] 0 0
Italy
State/province [238] 0 0
Lombardia
Country [239] 0 0
Italy
State/province [239] 0 0
Piemonte
Country [240] 0 0
Italy
State/province [240] 0 0
Sardegna
Country [241] 0 0
Italy
State/province [241] 0 0
Sicilia
Country [242] 0 0
Italy
State/province [242] 0 0
Toscana
Country [243] 0 0
Italy
State/province [243] 0 0
Veneto
Country [244] 0 0
Japan
State/province [244] 0 0
Aichi
Country [245] 0 0
Japan
State/province [245] 0 0
Chiba
Country [246] 0 0
Japan
State/province [246] 0 0
Ehime
Country [247] 0 0
Japan
State/province [247] 0 0
Fukuoka
Country [248] 0 0
Japan
State/province [248] 0 0
Fukushima
Country [249] 0 0
Japan
State/province [249] 0 0
Gifu
Country [250] 0 0
Japan
State/province [250] 0 0
Gunma
Country [251] 0 0
Japan
State/province [251] 0 0
Hiroshima
Country [252] 0 0
Japan
State/province [252] 0 0
Hokkaido
Country [253] 0 0
Japan
State/province [253] 0 0
Hyogo
Country [254] 0 0
Japan
State/province [254] 0 0
Ibaraki
Country [255] 0 0
Japan
State/province [255] 0 0
Ishikawa
Country [256] 0 0
Japan
State/province [256] 0 0
Kagawa
Country [257] 0 0
Japan
State/province [257] 0 0
Kanagawa
Country [258] 0 0
Japan
State/province [258] 0 0
Kumamoto
Country [259] 0 0
Japan
State/province [259] 0 0
Nagasaki
Country [260] 0 0
Japan
State/province [260] 0 0
Oita
Country [261] 0 0
Japan
State/province [261] 0 0
Okinawa
Country [262] 0 0
Japan
State/province [262] 0 0
Osaka
Country [263] 0 0
Japan
State/province [263] 0 0
Saitama
Country [264] 0 0
Japan
State/province [264] 0 0
Shiga
Country [265] 0 0
Japan
State/province [265] 0 0
Shizuoka
Country [266] 0 0
Japan
State/province [266] 0 0
Tochigi
Country [267] 0 0
Japan
State/province [267] 0 0
Tokyo
Country [268] 0 0
Japan
State/province [268] 0 0
Fukui
Country [269] 0 0
Japan
State/province [269] 0 0
Kagoshima
Country [270] 0 0
Korea, Republic of
State/province [270] 0 0
Gang''weondo
Country [271] 0 0
Korea, Republic of
State/province [271] 0 0
Gyeonggido
Country [272] 0 0
Korea, Republic of
State/province [272] 0 0
Seoul Teugbyeolsi
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Korea, Republic of
State/province [273] 0 0
Busan
Country [274] 0 0
Korea, Republic of
State/province [274] 0 0
Daegu
Country [275] 0 0
Korea, Republic of
State/province [275] 0 0
Seoul
Country [276] 0 0
Lithuania
State/province [276] 0 0
Kaunas
Country [277] 0 0
Lithuania
State/province [277] 0 0
Klaipeda
Country [278] 0 0
Lithuania
State/province [278] 0 0
Utena
Country [279] 0 0
Lithuania
State/province [279] 0 0
Vilnius
Country [280] 0 0
Malaysia
State/province [280] 0 0
Johor Bahru
Country [281] 0 0
Malaysia
State/province [281] 0 0
Kelantan
Country [282] 0 0
Malaysia
State/province [282] 0 0
Kuala Lumpur
Country [283] 0 0
Malaysia
State/province [283] 0 0
Pahang
Country [284] 0 0
Malaysia
State/province [284] 0 0
Perak
Country [285] 0 0
Malaysia
State/province [285] 0 0
Pulau Pinang
Country [286] 0 0
Malaysia
State/province [286] 0 0
Putrajaya
Country [287] 0 0
Malaysia
State/province [287] 0 0
Selangor
Country [288] 0 0
Mexico
State/province [288] 0 0
Distrito Federal
Country [289] 0 0
Mexico
State/province [289] 0 0
Jalisco
Country [290] 0 0
Mexico
State/province [290] 0 0
Morelos
Country [291] 0 0
Mexico
State/province [291] 0 0
Nuevo Leon
Country [292] 0 0
Mexico
State/province [292] 0 0
Querétaro
Country [293] 0 0
Mexico
State/province [293] 0 0
Sinaloa
Country [294] 0 0
Mexico
State/province [294] 0 0
Veracruz
Country [295] 0 0
Mexico
State/province [295] 0 0
Aguascalientes
Country [296] 0 0
Mexico
State/province [296] 0 0
Chihuahua
Country [297] 0 0
Mexico
State/province [297] 0 0
Durango
Country [298] 0 0
Netherlands
State/province [298] 0 0
Alkmaar
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Netherlands
State/province [299] 0 0
Almere
Country [300] 0 0
Netherlands
State/province [300] 0 0
Amersfoort
Country [301] 0 0
Netherlands
State/province [301] 0 0
Amsterdam
Country [302] 0 0
Netherlands
State/province [302] 0 0
Apeldoorn
Country [303] 0 0
Netherlands
State/province [303] 0 0
Breda
Country [304] 0 0
Netherlands
State/province [304] 0 0
Den Haag
Country [305] 0 0
Netherlands
State/province [305] 0 0
Eindhoven
Country [306] 0 0
Netherlands
State/province [306] 0 0
Geleen
Country [307] 0 0
Netherlands
State/province [307] 0 0
Groningen
Country [308] 0 0
Netherlands
State/province [308] 0 0
Hoogeveen
Country [309] 0 0
Netherlands
State/province [309] 0 0
Zwijndrecht
Country [310] 0 0
New Zealand
State/province [310] 0 0
Auckland
Country [311] 0 0
New Zealand
State/province [311] 0 0
Christchurch
Country [312] 0 0
New Zealand
State/province [312] 0 0
Hamilton
Country [313] 0 0
New Zealand
State/province [313] 0 0
Hawkes Bay
Country [314] 0 0
New Zealand
State/province [314] 0 0
Palmerston North
Country [315] 0 0
New Zealand
State/province [315] 0 0
Tauranga
Country [316] 0 0
New Zealand
State/province [316] 0 0
Wellington
Country [317] 0 0
Norway
State/province [317] 0 0
Hamar
Country [318] 0 0
Norway
State/province [318] 0 0
Kløfta
Country [319] 0 0
Norway
State/province [319] 0 0
Kongsvinger
Country [320] 0 0
Norway
State/province [320] 0 0
Kristiansand
Country [321] 0 0
Norway
State/province [321] 0 0
Levanger
Country [322] 0 0
Norway
State/province [322] 0 0
Lierskogen
Country [323] 0 0
Norway
State/province [323] 0 0
Oslo
Country [324] 0 0
Norway
State/province [324] 0 0
Skedsmokorset
Country [325] 0 0
Norway
State/province [325] 0 0
Ålesund
Country [326] 0 0
Philippines
State/province [326] 0 0
Iloilo City
Country [327] 0 0
Philippines
State/province [327] 0 0
Marikina City
Country [328] 0 0
Philippines
State/province [328] 0 0
Pasig City
Country [329] 0 0
Philippines
State/province [329] 0 0
Quezon City
Country [330] 0 0
Poland
State/province [330] 0 0
Bialystok
Country [331] 0 0
Poland
State/province [331] 0 0
Bydgoszcz
Country [332] 0 0
Poland
State/province [332] 0 0
Chojnice
Country [333] 0 0
Poland
State/province [333] 0 0
Gdansk
Country [334] 0 0
Poland
State/province [334] 0 0
Gdynia
Country [335] 0 0
Poland
State/province [335] 0 0
Katowice
Country [336] 0 0
Poland
State/province [336] 0 0
Krakow
Country [337] 0 0
Poland
State/province [337] 0 0
Lodz
Country [338] 0 0
Poland
State/province [338] 0 0
Lublin
Country [339] 0 0
Poland
State/province [339] 0 0
Poznan
Country [340] 0 0
Poland
State/province [340] 0 0
Rzeszow
Country [341] 0 0
Poland
State/province [341] 0 0
Skorzewo
Country [342] 0 0
Poland
State/province [342] 0 0
Szczecin
Country [343] 0 0
Poland
State/province [343] 0 0
Torun
Country [344] 0 0
Poland
State/province [344] 0 0
Warszawa
Country [345] 0 0
Poland
State/province [345] 0 0
Wroclaw
Country [346] 0 0
Poland
State/province [346] 0 0
Zabrze
Country [347] 0 0
Portugal
State/province [347] 0 0
Castelo Branco
Country [348] 0 0
Portugal
State/province [348] 0 0
Lisboa
Country [349] 0 0
Portugal
State/province [349] 0 0
Porto
Country [350] 0 0
Portugal
State/province [350] 0 0
Região Autónoma Da Madeira
Country [351] 0 0
Portugal
State/province [351] 0 0
Santarém
Country [352] 0 0
Portugal
State/province [352] 0 0
Setúbal
Country [353] 0 0
Portugal
State/province [353] 0 0
Almada
Country [354] 0 0
Portugal
State/province [354] 0 0
Amadora
Country [355] 0 0
Portugal
State/province [355] 0 0
Braga
Country [356] 0 0
Portugal
State/province [356] 0 0
Faro
Country [357] 0 0
Portugal
State/province [357] 0 0
Leiria
Country [358] 0 0
Portugal
State/province [358] 0 0
Viana do Castelo
Country [359] 0 0
Puerto Rico
State/province [359] 0 0
Cidra
Country [360] 0 0
Puerto Rico
State/province [360] 0 0
San Juan
Country [361] 0 0
Romania
State/province [361] 0 0
Alba
Country [362] 0 0
Romania
State/province [362] 0 0
Bihor
Country [363] 0 0
Romania
State/province [363] 0 0
Maramures
Country [364] 0 0
Romania
State/province [364] 0 0
Prahova
Country [365] 0 0
Romania
State/province [365] 0 0
Timis
Country [366] 0 0
Romania
State/province [366] 0 0
Brasov
Country [367] 0 0
Romania
State/province [367] 0 0
Bucuresti
Country [368] 0 0
Romania
State/province [368] 0 0
Cluj-Napoca
Country [369] 0 0
Romania
State/province [369] 0 0
Galati
Country [370] 0 0
Romania
State/province [370] 0 0
Iasi
Country [371] 0 0
Romania
State/province [371] 0 0
Oradea
Country [372] 0 0
Romania
State/province [372] 0 0
Satu Mare
Country [373] 0 0
Romania
State/province [373] 0 0
Timisoara
Country [374] 0 0
Russian Federation
State/province [374] 0 0
Arkhangelsk
Country [375] 0 0
Russian Federation
State/province [375] 0 0
Barnaul
Country [376] 0 0
Russian Federation
State/province [376] 0 0
Chelyabinsk
Country [377] 0 0
Russian Federation
State/province [377] 0 0
Irkutsk
Country [378] 0 0
Russian Federation
State/province [378] 0 0
Izhevsk
Country [379] 0 0
Russian Federation
State/province [379] 0 0
Kazan
Country [380] 0 0
Russian Federation
State/province [380] 0 0
Kemerovo
Country [381] 0 0
Russian Federation
State/province [381] 0 0
Kirov
Country [382] 0 0
Russian Federation
State/province [382] 0 0
Krasnodar
Country [383] 0 0
Russian Federation
State/province [383] 0 0
Krasnoyarsk
Country [384] 0 0
Russian Federation
State/province [384] 0 0
Kursk
Country [385] 0 0
Russian Federation
State/province [385] 0 0
Moscow
Country [386] 0 0
Russian Federation
State/province [386] 0 0
Nizhny Novgorod
Country [387] 0 0
Russian Federation
State/province [387] 0 0
Novosibirsk
Country [388] 0 0
Russian Federation
State/province [388] 0 0
Omsk
Country [389] 0 0
Russian Federation
State/province [389] 0 0
Orenburg
Country [390] 0 0
Russian Federation
State/province [390] 0 0
Perm
Country [391] 0 0
Russian Federation
State/province [391] 0 0
Saratov
Country [392] 0 0
Russian Federation
State/province [392] 0 0
St. Petersburg
Country [393] 0 0
Russian Federation
State/province [393] 0 0
Stavropol
Country [394] 0 0
Russian Federation
State/province [394] 0 0
Syktyvkar
Country [395] 0 0
Russian Federation
State/province [395] 0 0
Voronezh
Country [396] 0 0
Russian Federation
State/province [396] 0 0
Yaroslavl
Country [397] 0 0
Russian Federation
State/province [397] 0 0
Yekaterinburg
Country [398] 0 0
Singapore
State/province [398] 0 0
Singapore
Country [399] 0 0
Slovakia
State/province [399] 0 0
Banska Bystrica
Country [400] 0 0
Slovakia
State/province [400] 0 0
Bardejov
Country [401] 0 0
Slovakia
State/province [401] 0 0
Nitra
Country [402] 0 0
Slovakia
State/province [402] 0 0
Rimavska Sobota
Country [403] 0 0
Slovakia
State/province [403] 0 0
Roznava
Country [404] 0 0
Slovakia
State/province [404] 0 0
Zilina
Country [405] 0 0
South Africa
State/province [405] 0 0
Eastern Cape
Country [406] 0 0
South Africa
State/province [406] 0 0
Gauteng
Country [407] 0 0
South Africa
State/province [407] 0 0
Kwazulu-Natal
Country [408] 0 0
South Africa
State/province [408] 0 0
Mpumalanga
Country [409] 0 0
South Africa
State/province [409] 0 0
Western Cape
Country [410] 0 0
Spain
State/province [410] 0 0
A Coruña
Country [411] 0 0
Spain
State/province [411] 0 0
Barcelona
Country [412] 0 0
Spain
State/province [412] 0 0
Cádiz
Country [413] 0 0
Spain
State/province [413] 0 0
Lugo
Country [414] 0 0
Spain
State/province [414] 0 0
Madrid
Country [415] 0 0
Spain
State/province [415] 0 0
Valencia
Country [416] 0 0
Spain
State/province [416] 0 0
Córdoba
Country [417] 0 0
Spain
State/province [417] 0 0
Granada
Country [418] 0 0
Spain
State/province [418] 0 0
Jaén
Country [419] 0 0
Spain
State/province [419] 0 0
Málaga
Country [420] 0 0
Sweden
State/province [420] 0 0
Göteborg
Country [421] 0 0
Sweden
State/province [421] 0 0
Lund
Country [422] 0 0
Sweden
State/province [422] 0 0
Rättvik
Country [423] 0 0
Sweden
State/province [423] 0 0
Skövde
Country [424] 0 0
Sweden
State/province [424] 0 0
Stockholm
Country [425] 0 0
Sweden
State/province [425] 0 0
Uppsala
Country [426] 0 0
Sweden
State/province [426] 0 0
Örebro
Country [427] 0 0
Switzerland
State/province [427] 0 0
Sankt Gallen
Country [428] 0 0
Switzerland
State/province [428] 0 0
Solothurn
Country [429] 0 0
Switzerland
State/province [429] 0 0
Vaud
Country [430] 0 0
Switzerland
State/province [430] 0 0
Bern
Country [431] 0 0
Switzerland
State/province [431] 0 0
Genève
Country [432] 0 0
Taiwan
State/province [432] 0 0
Changhua
Country [433] 0 0
Taiwan
State/province [433] 0 0
Kaohsiung
Country [434] 0 0
Taiwan
State/province [434] 0 0
New Taipei City
Country [435] 0 0
Taiwan
State/province [435] 0 0
Taichung
Country [436] 0 0
Taiwan
State/province [436] 0 0
Taipei
Country [437] 0 0
Taiwan
State/province [437] 0 0
Taoyuan
Country [438] 0 0
Thailand
State/province [438] 0 0
Bangkok
Country [439] 0 0
Thailand
State/province [439] 0 0
Chiangmai
Country [440] 0 0
Thailand
State/province [440] 0 0
Khon Kaen
Country [441] 0 0
Turkey
State/province [441] 0 0
Ankara
Country [442] 0 0
Turkey
State/province [442] 0 0
Antalya
Country [443] 0 0
Turkey
State/province [443] 0 0
Aydin
Country [444] 0 0
Turkey
State/province [444] 0 0
Istanbul
Country [445] 0 0
Turkey
State/province [445] 0 0
Izmir
Country [446] 0 0
Turkey
State/province [446] 0 0
Kayseri
Country [447] 0 0
Turkey
State/province [447] 0 0
Kocaeli
Country [448] 0 0
Turkey
State/province [448] 0 0
Malatya
Country [449] 0 0
Turkey
State/province [449] 0 0
Sivas
Country [450] 0 0
Ukraine
State/province [450] 0 0
Cherkasy
Country [451] 0 0
Ukraine
State/province [451] 0 0
Chernivtsi
Country [452] 0 0
Ukraine
State/province [452] 0 0
Dnipro
Country [453] 0 0
Ukraine
State/province [453] 0 0
Ivano-Frankivsk
Country [454] 0 0
Ukraine
State/province [454] 0 0
Kharkiv
Country [455] 0 0
Ukraine
State/province [455] 0 0
Kiev
Country [456] 0 0
Ukraine
State/province [456] 0 0
Kyiv
Country [457] 0 0
Ukraine
State/province [457] 0 0
Lviv
Country [458] 0 0
Ukraine
State/province [458] 0 0
Mykolayiv
Country [459] 0 0
Ukraine
State/province [459] 0 0
Ternopil
Country [460] 0 0
Ukraine
State/province [460] 0 0
Vinnytsia
Country [461] 0 0
Ukraine
State/province [461] 0 0
Zaporizhzhya
Country [462] 0 0
Ukraine
State/province [462] 0 0
Zaporozhye
Country [463] 0 0
United Kingdom
State/province [463] 0 0
Carmarthenshire
Country [464] 0 0
United Kingdom
State/province [464] 0 0
Merseyside
Country [465] 0 0
United Kingdom
State/province [465] 0 0
Northamptonshire
Country [466] 0 0
United Kingdom
State/province [466] 0 0
Surrey
Country [467] 0 0
United Kingdom
State/province [467] 0 0
West Midlands
Country [468] 0 0
United Kingdom
State/province [468] 0 0
West Sussex
Country [469] 0 0
United Kingdom
State/province [469] 0 0
Bristol
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Glasgow
Country [471] 0 0
United Kingdom
State/province [471] 0 0
London
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Manchester
Country [473] 0 0
United Kingdom
State/province [473] 0 0
Middlesborough
Country [474] 0 0
Vietnam
State/province [474] 0 0
Ha Noi
Country [475] 0 0
Vietnam
State/province [475] 0 0
Ho Chi Minh City

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
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

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, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's 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