Back to resultsPhase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone (ARTS-HF)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Finerenone (BAY94-8862)
Placebo
Inspra (eplerenone)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Decompensation
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
- Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
- Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
- Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
- Subjects with type 2 diabetes mellitus and / or
- Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
- Left ventricular ejection fraction (LVEF) </= 40%
- Blood potassium </= 5.0 mmol/L at screening
- Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion Criteria:
- Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
- Acute coronary syndrome (ACS) in last 30 days prior to screening
- Cardiogenic shock
- Valvular heart disease requiring surgical intervention during the course of the study
- Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
- Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Finerenone(BAY94-8862)[2.5mg] + Placebo
Finerenone (BAY94-8862)[5mg] + Placebo
Finerenone (BAY94-8862)[7.5mg] + Placebo
Finerenone (BAY94-8862)[10mg] + Placebo
Finerenone (BAY94-8862)[15mg] + Placebo
Eplerenone [25 mg] + Placebo
Arm Description
Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.
Outcomes
Primary Outcome Measures
Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Secondary Outcome Measures
Number of Participants With Death Due to Any Cause
Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.
Number of Participants With Cardiovascular Hospitalization
Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.
Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.
Ratio of BNP at Specified Visits to BNP at Baseline
B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.
Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01807221
Brief Title
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
Acronym
ARTS-HF
Official Title
A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2013 (Actual)
Primary Completion Date
November 11, 2014 (Actual)
Study Completion Date
December 9, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Decompensation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1066 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Finerenone(BAY94-8862)[2.5mg] + Placebo
Arm Type
Experimental
Arm Description
Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Arm Title
Finerenone (BAY94-8862)[5mg] + Placebo
Arm Type
Experimental
Arm Description
Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Arm Title
Finerenone (BAY94-8862)[7.5mg] + Placebo
Arm Type
Experimental
Arm Description
Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Arm Title
Finerenone (BAY94-8862)[10mg] + Placebo
Arm Type
Experimental
Arm Description
Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Arm Title
Finerenone (BAY94-8862)[15mg] + Placebo
Arm Type
Experimental
Arm Description
Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
Arm Title
Eplerenone [25 mg] + Placebo
Arm Type
Active Comparator
Arm Description
Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.
Intervention Type
Drug
Intervention Name(s)
Finerenone (BAY94-8862)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Inspra (eplerenone)
Primary Outcome Measure Information:
Title
Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90
Description
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute and chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time Frame
Baseline and Day 90
Secondary Outcome Measure Information:
Title
Number of Participants With Death Due to Any Cause
Description
Death due to any cause include cardiovascular (CV) death and Non-CV death. Non-CV death was classified by 2 subcategories: non-malignant causes and malignant causes.
Time Frame
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Number of Participants With Cardiovascular Hospitalization
Description
Hospitalizations were defined as any unplanned admission to hospital, i.e. completion of hospital admission procedures and one overnight [i.e. date change] stay or until the death of subject occurred. Hospitalizations and deaths were classified by 2 primary categories: CV and non-CV. The pre-specified subcategories for CV hospitalizations were as follows: 1. Worsening heart failure, 2.Acute myocardial infarction, 3. Arrhythmia, 4.Transient ischemic attack and stroke, 5. Other CV hospitalizations.
Time Frame
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF)
Description
Emergency presentations for WCHF were defined as newly developing signs and symptoms of WCHF after start of treatment with study drug, requiring an additional emergency presentation to hospital and IV treatment with diuretics and/or positive inotropic agents.
Time Frame
Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Ratio of BNP at Specified Visits to BNP at Baseline
Description
B-type natriuretic peptide (BNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time Frame
Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline
Description
N-terminal pro-B type natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute chronic heart failure (CHF) and may be useful to establish prognosis in heart failure.
Time Frame
Day 30, Day 60, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Change From Baseline in KCCQ Questionnaire Scores at Specified Visits
Description
The Kansas City Cardiomyopathy Questionnaire (KCCQ) was the leading health related quality of life measure for subjects with CHF. KCCQ was a 23 item questionnaire that independently measures the impact of subjects HF, or its treatment, on 7 distinct domains: self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Results from the total symptom summary score are presented. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. In the below table, categorical data represents change from baseline data at respective time points.
Time Frame
Baseline, Day 30 and Day 90
Title
Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits
Description
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L): participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.
Time Frame
Baseline, Day 30, Day 90, Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Serum Potassium at Specified Visits
Time Frame
Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Change From Baseline in Systolic Blood Pressure at Specified Visits
Time Frame
Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Change From Baseline in Diastolic Blood Pressure at Specified Visits
Time Frame
Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
Title
Change From Baseline in Heart Rate at Specified Visits
Time Frame
Baseline,Day 7,14,30,60,90,Premature discontinuation (only for participants who have discontinued the study prematurely, to be performed as soon as possible after withdrawal of study drug) and Follow-up (30 days post-last dose, assessed up to Day 120)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
Subjects with type 2 diabetes mellitus and / or
Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
Left ventricular ejection fraction (LVEF) </= 40%
Blood potassium </= 5.0 mmol/L at screening
Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit
Exclusion Criteria:
Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
Acute coronary syndrome (ACS) in last 30 days prior to screening
Cardiogenic shock
Valvular heart disease requiring surgical intervention during the course of the study
Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2041
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
City
Concord
ZIP/Postal Code
2139
Country
Australia
City
Prahran
ZIP/Postal Code
3004
Country
Australia
City
Krems an der Donau
State/Province
Niederösterreich
ZIP/Postal Code
3500
Country
Austria
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8020
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Wien
ZIP/Postal Code
1100
Country
Austria
City
Burgas
ZIP/Postal Code
8018
Country
Bulgaria
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Saint-Jean-sur-Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1C3
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
City
Ostrava
ZIP/Postal Code
728 80
Country
Czechia
City
Praha 5
ZIP/Postal Code
150 30
Country
Czechia
City
Slany
ZIP/Postal Code
274 01
Country
Czechia
City
Copenhagen Ø
ZIP/Postal Code
2100
Country
Denmark
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
City
København NV
ZIP/Postal Code
2400
Country
Denmark
City
Køge
ZIP/Postal Code
4600
Country
Denmark
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
City
Espoo
ZIP/Postal Code
02740
Country
Finland
City
Helsinki
ZIP/Postal Code
00099
Country
Finland
City
Rovaniemi
ZIP/Postal Code
96101
Country
Finland
City
Turku
ZIP/Postal Code
20520
Country
Finland
City
Bron
ZIP/Postal Code
69677
Country
France
City
Nice
ZIP/Postal Code
06200
Country
France
City
PARIS cedex 10
ZIP/Postal Code
75475
Country
France
City
Paris cedex 13
ZIP/Postal Code
75013
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
City
Toulouse
ZIP/Postal Code
31403
Country
France
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97078
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
City
Limburg
State/Province
Hessen
ZIP/Postal Code
65549
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37099
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Stade
State/Province
Niedersachsen
ZIP/Postal Code
21682
Country
Germany
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32545
Country
Germany
City
Mönchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41063
Country
Germany
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Athens
ZIP/Postal Code
11526
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
City
Larissa
ZIP/Postal Code
41100
Country
Greece
City
Nea Ionia / Athens
ZIP/Postal Code
14233
Country
Greece
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
City
Afula
ZIP/Postal Code
1834111
Country
Israel
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Rehovot
ZIP/Postal Code
7610001
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
City
Zerifin
ZIP/Postal Code
7030000
Country
Israel
City
Roma
State/Province
Lazio
ZIP/Postal Code
00163
Country
Italy
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20149
Country
Italy
City
Monza Brianza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71100
Country
Italy
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52040
Country
Italy
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06129
Country
Italy
City
Wonju
State/Province
Gang''weondo
ZIP/Postal Code
26426
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Kaunas
ZIP/Postal Code
LT-44320
Country
Lithuania
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Amsterdam
ZIP/Postal Code
1061 AE
Country
Netherlands
City
Delft
ZIP/Postal Code
2625 AD
Country
Netherlands
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Szczecin
ZIP/Postal Code
70-965
Country
Poland
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
City
Lisboa
ZIP/Postal Code
1449-005
Country
Portugal
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
P-4200
Country
Portugal
City
Petoria
State/Province
Gauteng
Country
South Africa
City
Isipingo Rail
State/Province
Kwazulu-Natal
ZIP/Postal Code
4110
Country
South Africa
City
Merebank
State/Province
Kwazulu-Natal
ZIP/Postal Code
4052
Country
South Africa
City
Tongaat
State/Province
Kwazulu-Natal
ZIP/Postal Code
4400
Country
South Africa
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
City
Kuils River
State/Province
Western Cape
ZIP/Postal Code
7580
Country
South Africa
City
Pinelands
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Olot
State/Province
Girona
ZIP/Postal Code
17800
Country
Spain
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Falun
ZIP/Postal Code
791 82
Country
Sweden
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taizung
ZIP/Postal Code
402
Country
Taiwan
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
City
Ankara
Country
Turkey
City
Antalya
ZIP/Postal Code
07003
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
27130705
Citation
Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.
Results Reference
result
PubMed Identifier
33107592
Citation
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Results Reference
result
PubMed Identifier
25678098
Citation
Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.
Results Reference
result
Links:
URL
http://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer Healthcare products.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Learn more about this trial
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
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