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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02540993




Registration number
NCT02540993
Ethics application status
Date submitted
2/09/2015
Date registered
4/09/2015
Date last updated
24/07/2023

Titles & IDs
Public title
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Secondary ID [1] 0 0
2015-000990-11
Secondary ID [2] 0 0
16244
Universal Trial Number (UTN)
Trial acronym
FIDELIO-DKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
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: Finerenone (BAY94-8862) - Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

Placebo comparator: Placebo - Participants received matching placebo once daily in addition to standard of care therapy


Treatment: Drugs: Finerenone (BAY94-8862)
Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to \< 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR = 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Treatment: Drugs: Placebo
Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
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 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 primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months
Secondary 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 key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months
Secondary outcome [2] 0 0
All-cause Mortality
Timepoint [2] 0 0
From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months
Secondary outcome [3] 0 0
All-cause Hospitalization
Timepoint [3] 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 of 32 months
Secondary outcome [4] 0 0
Change in Urinary Albumin-to-creatinine Ratio (UACR) 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 composite primary endpoint, or censoring at the end of the study, with an average of 32 months

Eligibility
Key inclusion criteria
* Men or women =18 years of age
* Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
* Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

* persistent high albuminuria (UACR =30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) =25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
* persistent very high albuminuria (UACR =300 mg/g in 2 out of 3 first morning void samples) and eGFR =25 to <75 mL/min/1.73 m² (CKD-EPI)
* Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

* For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
* Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
* For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
* Serum potassium =4.8 mmol/L at both the run-in and the screening visit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) =170 mmHg, sitting diastolic blood pressure (DBP) =110 mmHg at run-in visit, or mean sitting SBP =160 mmHg, sitting DBP =100 mmHg at screening)
* Glycated hemoglobin (HbA1c) >12%
* Mean SBP < 90 mmHg at the run-in visit or at the screening visit
* 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 antagonists [MRAs])
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
* Dialysis for acute renal failure within 12 weeks of run-in visit
* Renal allograft in place or scheduled within next 12 months from the run-in visit

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
17/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2020
Sample size
Target
Accrual to date
Final
5734
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
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- Garran
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- Gosford
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- Liverpool
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- St. Albans
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- Box Hill
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- Elizabeth Vale
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3121 - Richmond
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3021 - St. Albans
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3128 - Box Hill
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5112 - Elizabeth Vale
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Greece
State/province [194] 0 0
Athens
Country [195] 0 0
Greece
State/province [195] 0 0
Chaidari
Country [196] 0 0
Greece
State/province [196] 0 0
Larissa
Country [197] 0 0
Greece
State/province [197] 0 0
Nea Ionia
Country [198] 0 0
Greece
State/province [198] 0 0
Thessaloniki
Country [199] 0 0
Hong Kong
State/province [199] 0 0
Hong Kong
Country [200] 0 0
Hong Kong
State/province [200] 0 0
Shatin
Country [201] 0 0
Hong Kong
State/province [201] 0 0
Sheung Wan
Country [202] 0 0
Hong Kong
State/province [202] 0 0
Wong Tai Sin
Country [203] 0 0
Hungary
State/province [203] 0 0
Baja
Country [204] 0 0
Hungary
State/province [204] 0 0
Balatonfured
Country [205] 0 0
Hungary
State/province [205] 0 0
Budapest
Country [206] 0 0
Hungary
State/province [206] 0 0
Debrecen
Country [207] 0 0
Hungary
State/province [207] 0 0
Eger
Country [208] 0 0
Hungary
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
Hungary
State/province [216] 0 0
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Country [217] 0 0
Ireland
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Cork
Country [218] 0 0
Ireland
State/province [218] 0 0
Dublin
Country [219] 0 0
Ireland
State/province [219] 0 0
Galway
Country [220] 0 0
Israel
State/province [220] 0 0
Afula
Country [221] 0 0
Israel
State/province [221] 0 0
Ashkelon
Country [222] 0 0
Israel
State/province [222] 0 0
Beer Sheva
Country [223] 0 0
Israel
State/province [223] 0 0
Hadera
Country [224] 0 0
Israel
State/province [224] 0 0
Haifa
Country [225] 0 0
Israel
State/province [225] 0 0
Holon
Country [226] 0 0
Israel
State/province [226] 0 0
Jerusalem
Country [227] 0 0
Israel
State/province [227] 0 0
Kfar Saba
Country [228] 0 0
Israel
State/province [228] 0 0
Nahariya
Country [229] 0 0
Israel
State/province [229] 0 0
Nazareth
Country [230] 0 0
Israel
State/province [230] 0 0
Ramat Gan
Country [231] 0 0
Israel
State/province [231] 0 0
Rehovot
Country [232] 0 0
Israel
State/province [232] 0 0
Sakhnin
Country [233] 0 0
Israel
State/province [233] 0 0
Tel Aviv
Country [234] 0 0
Israel
State/province [234] 0 0
Tiberias
Country [235] 0 0
Israel
State/province [235] 0 0
Zefat
Country [236] 0 0
Israel
State/province [236] 0 0
Zerifin
Country [237] 0 0
Italy
State/province [237] 0 0
Campania
Country [238] 0 0
Italy
State/province [238] 0 0
Emilia-Romagna
Country [239] 0 0
Italy
State/province [239] 0 0
Liguria
Country [240] 0 0
Italy
State/province [240] 0 0
Lombardia
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Italy
State/province [241] 0 0
Piemonte
Country [242] 0 0
Italy
State/province [242] 0 0
Sardegna
Country [243] 0 0
Italy
State/province [243] 0 0
Sicilia
Country [244] 0 0
Italy
State/province [244] 0 0
Veneto
Country [245] 0 0
Japan
State/province [245] 0 0
Aichi
Country [246] 0 0
Japan
State/province [246] 0 0
Chiba
Country [247] 0 0
Japan
State/province [247] 0 0
Ehime
Country [248] 0 0
Japan
State/province [248] 0 0
Fukuoka
Country [249] 0 0
Japan
State/province [249] 0 0
Fukushima
Country [250] 0 0
Japan
State/province [250] 0 0
Gifu
Country [251] 0 0
Japan
State/province [251] 0 0
Gunma
Country [252] 0 0
Japan
State/province [252] 0 0
Hiroshima
Country [253] 0 0
Japan
State/province [253] 0 0
Hokkaido
Country [254] 0 0
Japan
State/province [254] 0 0
Hyogo
Country [255] 0 0
Japan
State/province [255] 0 0
Ibaraki
Country [256] 0 0
Japan
State/province [256] 0 0
Ishikawa
Country [257] 0 0
Japan
State/province [257] 0 0
Kagawa
Country [258] 0 0
Japan
State/province [258] 0 0
Kanagawa
Country [259] 0 0
Japan
State/province [259] 0 0
Kumamoto
Country [260] 0 0
Japan
State/province [260] 0 0
Nagasaki
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Japan
State/province [261] 0 0
Oita
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Japan
State/province [262] 0 0
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Japan
State/province [263] 0 0
Osaka
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Japan
State/province [264] 0 0
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Country [265] 0 0
Japan
State/province [265] 0 0
Shiga
Country [266] 0 0
Japan
State/province [266] 0 0
Shizuoka
Country [267] 0 0
Japan
State/province [267] 0 0
Tochigi
Country [268] 0 0
Japan
State/province [268] 0 0
Tokyo
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Japan
State/province [269] 0 0
Fukui
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Japan
State/province [270] 0 0
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Korea, Republic of
State/province [271] 0 0
Gang''weondo
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Korea, Republic of
State/province [272] 0 0
Gyeonggido
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Korea, Republic of
State/province [273] 0 0
Incheon Gwang''yeogsi
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Korea, Republic of
State/province [274] 0 0
Seoul Teugbyeolsi
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Korea, Republic of
State/province [275] 0 0
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Korea, Republic of
State/province [276] 0 0
Daejeon
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Korea, Republic of
State/province [277] 0 0
Seoul,
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Korea, Republic of
State/province [278] 0 0
Seoul
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Utena
Country [282] 0 0
Lithuania
State/province [282] 0 0
Vilnius
Country [283] 0 0
Malaysia
State/province [283] 0 0
Johor Bahru
Country [284] 0 0
Malaysia
State/province [284] 0 0
Kelantan
Country [285] 0 0
Malaysia
State/province [285] 0 0
Kuala Lumpur
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Malaysia
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Pahang
Country [287] 0 0
Malaysia
State/province [287] 0 0
Perak
Country [288] 0 0
Malaysia
State/province [288] 0 0
Pulau Pinang
Country [289] 0 0
Malaysia
State/province [289] 0 0
Putrajaya
Country [290] 0 0
Malaysia
State/province [290] 0 0
Selangor
Country [291] 0 0
Mexico
State/province [291] 0 0
Distrito Federal
Country [292] 0 0
Mexico
State/province [292] 0 0
Jalisco
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Mexico
State/province [293] 0 0
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Mexico
State/province [294] 0 0
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Mexico
State/province [295] 0 0
Sinaloa
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Mexico
State/province [296] 0 0
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Mexico
State/province [297] 0 0
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Mexico
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Chihuahua
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Mexico
State/province [299] 0 0
Ciudad de México
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Netherlands
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Almere
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Apeldoorn
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Netherlands
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Netherlands
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Den Haag
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Netherlands
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Dordrecht
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Netherlands
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Eindhoven
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Netherlands
State/province [309] 0 0
Geleen
Country [310] 0 0
Netherlands
State/province [310] 0 0
Groningen
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Netherlands
State/province [311] 0 0
Hoogeveen
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Netherlands
State/province [312] 0 0
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Netherlands
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Auckland
Country [315] 0 0
New Zealand
State/province [315] 0 0
Christchurch
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New Zealand
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Hamilton
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New Zealand
State/province [317] 0 0
Hawkes Bay
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New Zealand
State/province [318] 0 0
Palmerston North
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New Zealand
State/province [319] 0 0
Tauranga
Country [320] 0 0
New Zealand
State/province [320] 0 0
Wellington
Country [321] 0 0
Norway
State/province [321] 0 0
Hamar
Country [322] 0 0
Norway
State/province [322] 0 0
Kløfta
Country [323] 0 0
Norway
State/province [323] 0 0
Kristiansand
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Norway
State/province [324] 0 0
Levanger
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Norway
State/province [325] 0 0
Oslo
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Norway
State/province [326] 0 0
Skedsmokorset
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Norway
State/province [327] 0 0
Trondheim
Country [328] 0 0
Norway
State/province [328] 0 0
Ålesund
Country [329] 0 0
Philippines
State/province [329] 0 0
Iloilo City
Country [330] 0 0
Philippines
State/province [330] 0 0
Marikina City
Country [331] 0 0
Philippines
State/province [331] 0 0
Pasig City
Country [332] 0 0
Philippines
State/province [332] 0 0
Quezon City
Country [333] 0 0
Poland
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Bialystok
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Poland
State/province [334] 0 0
Bydgoszcz
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Poland
State/province [335] 0 0
Chojnice
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Country [339] 0 0
Poland
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Krakow
Country [340] 0 0
Poland
State/province [340] 0 0
Lodz
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Poland
State/province [341] 0 0
Lublin
Country [342] 0 0
Poland
State/province [342] 0 0
Olsztyn
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Poland
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Poznan
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Poland
State/province [344] 0 0
Rzeszów
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Poland
State/province [345] 0 0
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Poland
State/province [346] 0 0
Szczecin
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Poland
State/province [347] 0 0
Torun
Country [348] 0 0
Poland
State/province [348] 0 0
Warszawa
Country [349] 0 0
Poland
State/province [349] 0 0
Wroclaw
Country [350] 0 0
Poland
State/province [350] 0 0
Zabrze
Country [351] 0 0
Portugal
State/province [351] 0 0
Castelo Branco
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Portugal
State/province [352] 0 0
Lisboa
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Portugal
State/province [353] 0 0
Porto
Country [354] 0 0
Portugal
State/province [354] 0 0
Região Autónoma Da Madeira
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Portugal
State/province [355] 0 0
Santarém
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Portugal
State/province [356] 0 0
Setúbal
Country [357] 0 0
Portugal
State/province [357] 0 0
Almada
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Portugal
State/province [358] 0 0
Amadora
Country [359] 0 0
Portugal
State/province [359] 0 0
Braga
Country [360] 0 0
Portugal
State/province [360] 0 0
Faro
Country [361] 0 0
Portugal
State/province [361] 0 0
Leiria
Country [362] 0 0
Portugal
State/province [362] 0 0
Viana do Castelo
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Puerto Rico
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Cidra
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Puerto Rico
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San Juan
Country [365] 0 0
Romania
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Alba
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Romania
State/province [366] 0 0
Maramures
Country [367] 0 0
Romania
State/province [367] 0 0
Prahova
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Romania
State/province [368] 0 0
Timis
Country [369] 0 0
Romania
State/province [369] 0 0
Bucuresti
Country [370] 0 0
Romania
State/province [370] 0 0
Cluj-Napoca
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Romania
State/province [371] 0 0
Galati
Country [372] 0 0
Romania
State/province [372] 0 0
Iasi
Country [373] 0 0
Romania
State/province [373] 0 0
Oradea
Country [374] 0 0
Romania
State/province [374] 0 0
Satu Mare
Country [375] 0 0
Romania
State/province [375] 0 0
Timisoara
Country [376] 0 0
Russian Federation
State/province [376] 0 0
Arkhangelsk
Country [377] 0 0
Russian Federation
State/province [377] 0 0
Barnaul
Country [378] 0 0
Russian Federation
State/province [378] 0 0
Chelyabinsk
Country [379] 0 0
Russian Federation
State/province [379] 0 0
Irkutsk
Country [380] 0 0
Russian Federation
State/province [380] 0 0
Izhevsk
Country [381] 0 0
Russian Federation
State/province [381] 0 0
Kazan
Country [382] 0 0
Russian Federation
State/province [382] 0 0
Kemerovo
Country [383] 0 0
Russian Federation
State/province [383] 0 0
Kirov
Country [384] 0 0
Russian Federation
State/province [384] 0 0
Krasnodar
Country [385] 0 0
Russian Federation
State/province [385] 0 0
Krasnoyarsk
Country [386] 0 0
Russian Federation
State/province [386] 0 0
Kursk
Country [387] 0 0
Russian Federation
State/province [387] 0 0
Moscow
Country [388] 0 0
Russian Federation
State/province [388] 0 0
Nizhny Novgorod
Country [389] 0 0
Russian Federation
State/province [389] 0 0
Novosibirsk
Country [390] 0 0
Russian Federation
State/province [390] 0 0
Omsk
Country [391] 0 0
Russian Federation
State/province [391] 0 0
Orenburg
Country [392] 0 0
Russian Federation
State/province [392] 0 0
Perm
Country [393] 0 0
Russian Federation
State/province [393] 0 0
Ryazan
Country [394] 0 0
Russian Federation
State/province [394] 0 0
Saratov
Country [395] 0 0
Russian Federation
State/province [395] 0 0
St. Petersburg
Country [396] 0 0
Russian Federation
State/province [396] 0 0
Stavropol
Country [397] 0 0
Russian Federation
State/province [397] 0 0
Syktyvkar
Country [398] 0 0
Russian Federation
State/province [398] 0 0
Voronezh
Country [399] 0 0
Russian Federation
State/province [399] 0 0
Yaroslavl
Country [400] 0 0
Russian Federation
State/province [400] 0 0
Yekaterinburg
Country [401] 0 0
Singapore
State/province [401] 0 0
Singapore
Country [402] 0 0
Slovakia
State/province [402] 0 0
Bardejov
Country [403] 0 0
Slovakia
State/province [403] 0 0
Nitra
Country [404] 0 0
Slovakia
State/province [404] 0 0
Rimavska Sobota
Country [405] 0 0
Slovakia
State/province [405] 0 0
Roznava
Country [406] 0 0
Slovakia
State/province [406] 0 0
Zilina
Country [407] 0 0
South Africa
State/province [407] 0 0
Eastern Cape
Country [408] 0 0
South Africa
State/province [408] 0 0
Gauteng
Country [409] 0 0
South Africa
State/province [409] 0 0
Kwazulu-Natal
Country [410] 0 0
South Africa
State/province [410] 0 0
Mpumalanga
Country [411] 0 0
South Africa
State/province [411] 0 0
Western Cape
Country [412] 0 0
South Africa
State/province [412] 0 0
Pretoria
Country [413] 0 0
Spain
State/province [413] 0 0
A Coruña
Country [414] 0 0
Spain
State/province [414] 0 0
Barcelona
Country [415] 0 0
Spain
State/province [415] 0 0
Cádiz
Country [416] 0 0
Spain
State/province [416] 0 0
Lugo
Country [417] 0 0
Spain
State/province [417] 0 0
Madrid
Country [418] 0 0
Spain
State/province [418] 0 0
Valencia
Country [419] 0 0
Spain
State/province [419] 0 0
Córdoba
Country [420] 0 0
Spain
State/province [420] 0 0
Granada
Country [421] 0 0
Spain
State/province [421] 0 0
Jaén
Country [422] 0 0
Spain
State/province [422] 0 0
Málaga
Country [423] 0 0
Sweden
State/province [423] 0 0
Göteborg
Country [424] 0 0
Sweden
State/province [424] 0 0
Lund
Country [425] 0 0
Sweden
State/province [425] 0 0
Rättvik
Country [426] 0 0
Sweden
State/province [426] 0 0
Skövde
Country [427] 0 0
Sweden
State/province [427] 0 0
Stockholm
Country [428] 0 0
Sweden
State/province [428] 0 0
Uppsala
Country [429] 0 0
Sweden
State/province [429] 0 0
Örebro
Country [430] 0 0
Switzerland
State/province [430] 0 0
Basel-Landschaft
Country [431] 0 0
Switzerland
State/province [431] 0 0
Genève
Country [432] 0 0
Switzerland
State/province [432] 0 0
Sankt Gallen
Country [433] 0 0
Switzerland
State/province [433] 0 0
Solothurn
Country [434] 0 0
Switzerland
State/province [434] 0 0
Thurgau
Country [435] 0 0
Switzerland
State/province [435] 0 0
Vaud
Country [436] 0 0
Switzerland
State/province [436] 0 0
Bern
Country [437] 0 0
Taiwan
State/province [437] 0 0
Changhua
Country [438] 0 0
Taiwan
State/province [438] 0 0
Kaohsiung
Country [439] 0 0
Taiwan
State/province [439] 0 0
New Taipei City
Country [440] 0 0
Taiwan
State/province [440] 0 0
Taichung
Country [441] 0 0
Taiwan
State/province [441] 0 0
Taipei
Country [442] 0 0
Taiwan
State/province [442] 0 0
Taoyuan
Country [443] 0 0
Thailand
State/province [443] 0 0
Bangkok
Country [444] 0 0
Thailand
State/province [444] 0 0
Chiangmai
Country [445] 0 0
Thailand
State/province [445] 0 0
Khon Kaen
Country [446] 0 0
Turkey
State/province [446] 0 0
Ankara
Country [447] 0 0
Turkey
State/province [447] 0 0
Antalya
Country [448] 0 0
Turkey
State/province [448] 0 0
Edirne
Country [449] 0 0
Turkey
State/province [449] 0 0
Izmir
Country [450] 0 0
Turkey
State/province [450] 0 0
Kayseri
Country [451] 0 0
Turkey
State/province [451] 0 0
Kocaeli
Country [452] 0 0
Turkey
State/province [452] 0 0
Malatya
Country [453] 0 0
Turkey
State/province [453] 0 0
Samsun
Country [454] 0 0
Turkey
State/province [454] 0 0
Sivas
Country [455] 0 0
Ukraine
State/province [455] 0 0
Cherkasy
Country [456] 0 0
Ukraine
State/province [456] 0 0
Chernivtsi
Country [457] 0 0
Ukraine
State/province [457] 0 0
Dnipro
Country [458] 0 0
Ukraine
State/province [458] 0 0
Ivano-Frankivsk
Country [459] 0 0
Ukraine
State/province [459] 0 0
Kharkiv
Country [460] 0 0
Ukraine
State/province [460] 0 0
Kiev
Country [461] 0 0
Ukraine
State/province [461] 0 0
Kyiv
Country [462] 0 0
Ukraine
State/province [462] 0 0
Lviv
Country [463] 0 0
Ukraine
State/province [463] 0 0
Mykolayiv
Country [464] 0 0
Ukraine
State/province [464] 0 0
Ternopil
Country [465] 0 0
Ukraine
State/province [465] 0 0
Uzhgorod
Country [466] 0 0
Ukraine
State/province [466] 0 0
Vinnytsia
Country [467] 0 0
Ukraine
State/province [467] 0 0
Zaporizhzhya
Country [468] 0 0
United Kingdom
State/province [468] 0 0
Carmarthenshire
Country [469] 0 0
United Kingdom
State/province [469] 0 0
Leicestershire
Country [470] 0 0
United Kingdom
State/province [470] 0 0
Manchester
Country [471] 0 0
United Kingdom
State/province [471] 0 0
Merseyside
Country [472] 0 0
United Kingdom
State/province [472] 0 0
Northamptonshire
Country [473] 0 0
United Kingdom
State/province [473] 0 0
Surrey
Country [474] 0 0
United Kingdom
State/province [474] 0 0
Vale Of Glamorgan, The
Country [475] 0 0
United Kingdom
State/province [475] 0 0
West Sussex
Country [476] 0 0
United Kingdom
State/province [476] 0 0
Bristol
Country [477] 0 0
United Kingdom
State/province [477] 0 0
London
Country [478] 0 0
United Kingdom
State/province [478] 0 0
Middlesborough
Country [479] 0 0
United Kingdom
State/province [479] 0 0
Portsmouth
Country [480] 0 0
Vietnam
State/province [480] 0 0
Ha Noi
Country [481] 0 0
Vietnam
State/province [481] 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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT02540993