Heart Failure
Conditions
Keywords
Heart Decompensation
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.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | Baseline and 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120) | 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 | 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) | 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 | 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) | 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 | Baseline, Day 30 and Day 90 | 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 | 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) | 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. |
| Number of Participants With Death Due to Any Cause | Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120) | 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 | Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120) | 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. |
Other
| Measure | Time frame |
|---|---|
| Change From Baseline in Diastolic Blood Pressure at Specified Visits | 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) |
| Change From Baseline in Heart Rate at Specified Visits | 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) |
| Change From Baseline in Serum Potassium at Specified Visits | Baseline, Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120) |
| Change From Baseline in Systolic Blood Pressure at Specified Visits | 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) |
Countries
Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Participant flow
Recruitment details
Study was conducted in 168 study centers in 25 countries worldwide, from 17 June 2013 (first participant first visit) to 09 December 2014 (last participant last visit).
Pre-assignment details
Out of 1286 screened participants, 1066 participants were randomized, 1055 participants received study treatment and were valid for safety analysis set.
Participants by arm
| Arm | Count |
|---|---|
| Eplerenone (INSPRA®) Eplerenone 25 milligram (mg) capsule every other day (EOD), on Day 1, Day 3, Day 5, etc, along with placebo capsule (matched to Eplerenone capsule) on Day 2, Day 4, Day 6, etc., and placebo tablet (matched to Finerenone tablet) once daily (OD).The dose could be increased to 25 mg OD at Day 30 and to 50 mg OD at Day 60 (or 25 mg OD if no up-titration occurred on Day 30) if both up-titration steps were performed. Treatment duration was for 90 days. | 221 |
| Finerenone (BAY94-8862) 2.5-5 mg OD Finerenone 2.5 mg immediate-release (IR) tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 5 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days. | 172 |
| Finerenone (BAY94-8862) 5-10 mg OD Finerenone 5 mg IR tablets OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 10 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days. | 163 |
| Finerenone (BAY94-8862) 7.5-15 mg OD Finerenone 7.5 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 15 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days. | 167 |
| Finerenone (BAY94-8862) 10-20 mg OD Finerenone 10 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days. | 169 |
| Finerenone (BAY94-8862) 15-20 mg OD Finerenone 15 mg IR tablet OD and placebo capsule (matched to Eplerenone capsule) OD, with possible up-titration to 20 mg OD at Day 30 (Day 30±2) and sham up-titration at Day 60 (Day 60±2). Treatment duration was for 90 days. | 163 |
| Total | 1,055 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 33 | 22 | 26 | 25 | 18 | 21 |
| Overall Study | Death | 7 | 9 | 4 | 2 | 1 | 6 |
| Overall Study | Logistical difficulties | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 1 | 0 | 0 |
| Overall Study | Non-compliance | 1 | 2 | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Progressive disease | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 1 | 2 | 0 | 1 |
| Overall Study | Sponsor decision | 2 | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 33 | 15 | 8 | 14 | 16 | 13 |
Baseline characteristics
| Characteristic | Eplerenone (INSPRA®) | Finerenone (BAY94-8862) 2.5-5 mg OD | Finerenone (BAY94-8862) 5-10 mg OD | Finerenone (BAY94-8862) 7.5-15 mg OD | Finerenone (BAY94-8862) 10-20 mg OD | Finerenone (BAY94-8862) 15-20 mg OD | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 72.38 years STANDARD_DEVIATION 9.92 | 72.53 years STANDARD_DEVIATION 9.74 | 71.81 years STANDARD_DEVIATION 10.55 | 69.27 years STANDARD_DEVIATION 9.83 | 71.27 years STANDARD_DEVIATION 10.27 | 69.2 years STANDARD_DEVIATION 10.15 | 71.15 years STANDARD_DEVIATION 10.14 |
| Baseline BNP | 594.290 pg/ml STANDARD_DEVIATION 2.601 | 677.906 pg/ml STANDARD_DEVIATION 2.637 | 574.245 pg/ml STANDARD_DEVIATION 2.543 | 570.776 pg/ml STANDARD_DEVIATION 2.741 | 606.080 pg/ml STANDARD_DEVIATION 2.598 | 552.032 pg/ml STANDARD_DEVIATION 2.698 | 594.732 pg/ml STANDARD_DEVIATION 2.634 |
| Baseline NT-proBNP | 4730.170 pg/ml STANDARD_DEVIATION 2.938 | 4793.430 pg/ml STANDARD_DEVIATION 3.084 | 4184.631 pg/ml STANDARD_DEVIATION 3.093 | 3776.859 pg/ml STANDARD_DEVIATION 3.395 | 4163.898 pg/ml STANDARD_DEVIATION 2.734 | 3791.677 pg/ml STANDARD_DEVIATION 3.013 | 4246.883 pg/ml STANDARD_DEVIATION 3.04 |
| Sex: Female, Male Female | 51 Participants | 37 Participants | 37 Participants | 43 Participants | 41 Participants | 31 Participants | 240 Participants |
| Sex: Female, Male Male | 170 Participants | 135 Participants | 126 Participants | 124 Participants | 128 Participants | 132 Participants | 815 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 221 | 17 / 172 | 9 / 163 | 12 / 167 | 2 / 169 | 9 / 163 |
| other Total, other adverse events | 85 / 221 | 63 / 172 | 59 / 163 | 50 / 167 | 50 / 169 | 65 / 163 |
| serious Total, serious adverse events | 77 / 221 | 72 / 172 | 47 / 163 | 52 / 167 | 46 / 169 | 57 / 163 |
Outcome results
Primary
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.
Time frame: Baseline and Day 90
Population: Full analysis set (FAS): all participants who the study drug, had baseline and at least one post-baseline NT-proBNP value or who died or experienced permanent (≥5 consecutive days) withdrawal of study drug after cardiovascular (CV) hospitalization or after emergency presentation for Worsening Chronic Heart Failure (WCHF)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Eplerenone (INSPRA®) | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 37.2 Percentage of participants | 90% Confidence Interval 31.6 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 30.9 Percentage of participants | 90% Confidence Interval 24.9 |
| Finerenone (BAY94-8862) 5-10 mg OD | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 32.5 Percentage of participants | 90% Confidence Interval 26.3 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 37.3 Percentage of participants | 90% Confidence Interval 30.9 |
| Finerenone (BAY94-8862) 10-20 mg OD | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 38.8 Percentage of participants | 90% Confidence Interval 32.3 |
| Finerenone (BAY94-8862) 15-20 mg OD | Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 | 34.2 Percentage of participants | 90% Confidence Interval 27.9 |
Comparison: Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.p-value: 0.877190% CI: [-14.9, 2.3]Chi-squared
Comparison: Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.p-value: 0.794590% CI: [-13.4, 4]Chi-squared
Comparison: Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.p-value: 0.590% CI: [-8.5, 8.8]Chi-squared
Comparison: Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearsonconfidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.p-value: 0.422590% CI: [-7.1, 10.2]Chi-squared
Comparison: Estimates and two-sided 90% confidence intervals are provided for each treatment group and for the treatment differences πBi - πC. Clopper-Pearson confidence intervals were calculated for each treatment group, while for treatment differences the exact unconditional confidence limits were calculated.p-value: 0.686590% CI: [-11.7, 5.7]Chi-squared
Secondary
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.
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)
Population: Participants in FAS with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | -0.12 Scores on scale | Standard Deviation 0.25 |
| Eplerenone (INSPRA®) | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.06 Scores on scale | Standard Deviation 0.23 |
| Eplerenone (INSPRA®) | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.58 Scores on scale | Standard Deviation 0.25 |
| Eplerenone (INSPRA®) | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.06 Scores on scale | Standard Deviation 0.26 |
| Eplerenone (INSPRA®) | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.08 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.02 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | -0.06 Scores on scale | Standard Deviation 0.29 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.59 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.01 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.03 Scores on scale | Standard Deviation 0.27 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.02 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | -0.09 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.01 Scores on scale | Standard Deviation 0.27 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.04 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.62 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.08 Scores on scale | Standard Deviation 0.2 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.58 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.07 Scores on scale | Standard Deviation 0.22 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | -0.1 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.08 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | -0.05 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.56 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.07 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.06 Scores on scale | Standard Deviation 0.23 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.1 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Baseline | 0.59 Scores on scale | Standard Deviation 0.24 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Premature discontinuation | 0 Scores on scale | Standard Deviation 0.29 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 30 | 0.02 Scores on scale | Standard Deviation 0.25 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Follow-up | 0.04 Scores on scale | Standard Deviation 0.28 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in EQ-5D-3L Questionnaire Scores at Specified Visits | Day 90 | 0.06 Scores on scale | Standard Deviation 0.28 |
Secondary
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.
Time frame: Baseline, Day 30 and Day 90
Population: Participants in FAS with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 20.5 Scores on a scale | Standard Deviation 26.2 |
| Eplerenone (INSPRA®) | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 43.7 Scores on a scale | Standard Deviation 23 |
| Eplerenone (INSPRA®) | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 24.3 Scores on a scale | Standard Deviation 27.6 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 18.2 Scores on a scale | Standard Deviation 22.7 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 42.8 Scores on a scale | Standard Deviation 22.6 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 21.3 Scores on a scale | Standard Deviation 27.2 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 19.3 Scores on a scale | Standard Deviation 26.5 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 45.4 Scores on a scale | Standard Deviation 24 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 24.5 Scores on a scale | Standard Deviation 27 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 23 Scores on a scale | Standard Deviation 24.4 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 42.1 Scores on a scale | Standard Deviation 23.2 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 29.3 Scores on a scale | Standard Deviation 28.6 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 24.9 Scores on a scale | Standard Deviation 22.9 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 42.3 Scores on a scale | Standard Deviation 23.7 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 28.3 Scores on a scale | Standard Deviation 23.8 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Baseline | 43.2 Scores on a scale | Standard Deviation 22.5 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 90 | 22.2 Scores on a scale | Standard Deviation 30.6 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in KCCQ Questionnaire Scores at Specified Visits | Day 30 | 20.6 Scores on a scale | Standard Deviation 27 |
Secondary
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.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Population: Participants in FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eplerenone (INSPRA®) | Number of Participants With Cardiovascular Hospitalization | Day 30 | 28 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Cardiovascular Hospitalization | Day 60 | 43 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Cardiovascular Hospitalization | Day 90 | 45 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Cardiovascular Hospitalization | Follow-up | 56 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 90 | 35 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 60 | 33 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 30 | 23 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Cardiovascular Hospitalization | Follow-up | 43 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Cardiovascular Hospitalization | Follow-up | 38 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 90 | 26 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 60 | 23 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 30 | 14 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 30 | 8 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Cardiovascular Hospitalization | Follow-up | 36 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 60 | 21 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 90 | 29 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 90 | 22 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Follow-up | 27 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 60 | 15 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 30 | 7 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 60 | 23 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 90 | 28 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Follow-up | 34 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Cardiovascular Hospitalization | Day 30 | 15 Participants |
Secondary
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.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Population: Participants in FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eplerenone (INSPRA®) | Number of Participants With Death Due to Any Cause | Day 30 | 6 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Death Due to Any Cause | Day 60 | 7 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Death Due to Any Cause | Day 90 | 9 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Death Due to Any Cause | Follow-up | 15 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Death Due to Any Cause | Day 90 | 10 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Death Due to Any Cause | Day 60 | 7 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Death Due to Any Cause | Day 30 | 5 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Death Due to Any Cause | Follow-up | 16 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Death Due to Any Cause | Follow-up | 7 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Death Due to Any Cause | Day 90 | 4 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Death Due to Any Cause | Day 60 | 3 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Death Due to Any Cause | Day 30 | 1 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Death Due to Any Cause | Day 30 | 1 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Death Due to Any Cause | Follow-up | 11 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Death Due to Any Cause | Day 60 | 2 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Death Due to Any Cause | Day 90 | 4 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Death Due to Any Cause | Day 90 | 1 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Death Due to Any Cause | Follow-up | 2 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Death Due to Any Cause | Day 60 | 0 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Death Due to Any Cause | Day 30 | 0 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Death Due to Any Cause | Day 60 | 4 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Death Due to Any Cause | Day 90 | 5 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Death Due to Any Cause | Follow-up | 8 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Death Due to Any Cause | Day 30 | 2 Participants |
Secondary
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.
Time frame: Day 30, Day 60, Day 90 and Follow-up (30 days post-last dose, assessed up to Day 120)
Population: Participants in FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eplerenone (INSPRA®) | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 21 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 35 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 37 Participants |
| Eplerenone (INSPRA®) | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 47 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 32 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 30 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 19 Participants |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 40 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 30 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 22 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 20 Participants |
| Finerenone (BAY94-8862) 5-10 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 12 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 9 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 30 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 17 Participants |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 24 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 18 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 26 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 14 Participants |
| Finerenone (BAY94-8862) 10-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 7 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 60 | 22 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 90 | 28 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Follow-up | 34 Participants |
| Finerenone (BAY94-8862) 15-20 mg OD | Number of Participants With Emergency Presentations for Worsening Chronic Heart Failure (WCHF) | Day 30 | 15 Participants |
Secondary
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.
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)
Population: Participants in FAS with valid data at specified visits
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 0.896 Ratio | Standard Deviation 0.896 |
| Eplerenone (INSPRA®) | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.783 Ratio | Standard Deviation 2.194 |
| Eplerenone (INSPRA®) | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.925 Ratio | Standard Deviation 2.02 |
| Eplerenone (INSPRA®) | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.795 Ratio | Standard Deviation 2.232 |
| Eplerenone (INSPRA®) | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.723 Ratio | Standard Deviation 2.202 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.864 Ratio | Standard Deviation 2.139 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 1.104 Ratio | Standard Deviation 2.15 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.944 Ratio | Standard Deviation 1.952 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.815 Ratio | Standard Deviation 2.388 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.813 Ratio | Standard Deviation 2.412 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.854 Ratio | Standard Deviation 1.854 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 1.006 Ratio | Standard Deviation 2.422 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.886 Ratio | Standard Deviation 2.199 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.839 Ratio | Standard Deviation 1.93 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.878 Ratio | Standard Deviation 1.713 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.719 Ratio | Standard Deviation 2.204 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.832 Ratio | Standard Deviation 1.959 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.79 Ratio | Standard Deviation 2.179 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 0.884 Ratio | Standard Deviation 1.973 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.726 Ratio | Standard Deviation 2.397 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 0.848 Ratio | Standard Deviation 2.218 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.852 Ratio | Standard Deviation 1.901 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.729 Ratio | Standard Deviation 2.487 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.711 Ratio | Standard Deviation 2.116 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.706 Ratio | Standard Deviation 2.34 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 30 | 0.879 Ratio | Standard Deviation 1.968 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Premature discontinuation | 1.044 Ratio | Standard Deviation 2.174 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 60 | 0.824 Ratio | Standard Deviation 2.142 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Follow-up | 0.852 Ratio | Standard Deviation 2.169 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of BNP at Specified Visits to BNP at Baseline | Day 90 | 0.771 Ratio | Standard Deviation 2.197 |
Secondary
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.
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)
Population: Participants in FAS with valid data at specified visits
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 0.948 Ratio | Standard Deviation 2.684 |
| Eplerenone (INSPRA®) | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.749 Ratio | Standard Deviation 2.73 |
| Eplerenone (INSPRA®) | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.883 Ratio | Standard Deviation 2.458 |
| Eplerenone (INSPRA®) | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.747 Ratio | Standard Deviation 2.616 |
| Eplerenone (INSPRA®) | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.688 Ratio | Standard Deviation 2.59 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.822 Ratio | Standard Deviation 2.423 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 1.369 Ratio | Standard Deviation 2.087 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.98 Ratio | Standard Deviation 2.158 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.747 Ratio | Standard Deviation 2.741 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.789 Ratio | Standard Deviation 2.661 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.814 Ratio | Standard Deviation 2.178 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 1.267 Ratio | Standard Deviation 2.261 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.887 Ratio | Standard Deviation 2.604 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.765 Ratio | Standard Deviation 2.214 |
| Finerenone (BAY94-8862) 5-10 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.874 Ratio | Standard Deviation 2.14 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.783 Ratio | Standard Deviation 2.454 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.888 Ratio | Standard Deviation 2.123 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.81 Ratio | Standard Deviation 2.268 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 0.927 Ratio | Standard Deviation 1.864 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.809 Ratio | Standard Deviation 2.647 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 1.133 Ratio | Standard Deviation 2.981 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.822 Ratio | Standard Deviation 2.217 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.746 Ratio | Standard Deviation 2.472 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.748 Ratio | Standard Deviation 2.496 |
| Finerenone (BAY94-8862) 10-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.728 Ratio | Standard Deviation 2.795 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 30 | 0.921 Ratio | Standard Deviation 2.136 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Premature discontinuation | 0.965 Ratio | Standard Deviation 2.352 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 60 | 0.829 Ratio | Standard Deviation 2.288 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Follow-up | 0.849 Ratio | Standard Deviation 2.348 |
| Finerenone (BAY94-8862) 15-20 mg OD | Ratio of NT-proBNP at Specified Visits to NT-proBNP at Baseline | Day 90 | 0.771 Ratio | Standard Deviation 2.471 |
Other Pre-specified
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)
Population: Participants in SAF with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | -3.442 millimeter for mercury (mmHg) | Standard Deviation 10.089 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | -1.351 millimeter for mercury (mmHg) | Standard Deviation 10.237 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 71.633 millimeter for mercury (mmHg) | Standard Deviation 11.647 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | -0.503 millimeter for mercury (mmHg) | Standard Deviation 10.826 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | -0.613 millimeter for mercury (mmHg) | Standard Deviation 11.096 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -0.716 millimeter for mercury (mmHg) | Standard Deviation 11.035 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | -3.185 millimeter for mercury (mmHg) | Standard Deviation 11.853 |
| Eplerenone (INSPRA®) | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | -1.218 millimeter for mercury (mmHg) | Standard Deviation 11.477 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | 0.146 millimeter for mercury (mmHg) | Standard Deviation 10.667 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | 0.696 millimeter for mercury (mmHg) | Standard Deviation 13.172 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 71.044 millimeter for mercury (mmHg) | Standard Deviation 10.762 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | 0.868 millimeter for mercury (mmHg) | Standard Deviation 9.239 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -0.106 millimeter for mercury (mmHg) | Standard Deviation 11.148 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | -0.537 millimeter for mercury (mmHg) | Standard Deviation 9.59 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | -1.693 millimeter for mercury (mmHg) | Standard Deviation 9.911 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | -0.199 millimeter for mercury (mmHg) | Standard Deviation 11.297 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | -2.143 millimeter for mercury (mmHg) | Standard Deviation 9.848 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | 1.608 millimeter for mercury (mmHg) | Standard Deviation 9.423 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | -0.845 millimeter for mercury (mmHg) | Standard Deviation 8.91 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | -0.444 millimeter for mercury (mmHg) | Standard Deviation 10.197 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | -2.144 millimeter for mercury (mmHg) | Standard Deviation 9.552 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -1.738 millimeter for mercury (mmHg) | Standard Deviation 9.015 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | -2.194 millimeter for mercury (mmHg) | Standard Deviation 15.522 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 71.442 millimeter for mercury (mmHg) | Standard Deviation 8.508 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | 4.101 millimeter for mercury (mmHg) | Standard Deviation 12.151 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -1.121 millimeter for mercury (mmHg) | Standard Deviation 9.96 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | -0.85 millimeter for mercury (mmHg) | Standard Deviation 10.472 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 70.61 millimeter for mercury (mmHg) | Standard Deviation 9.692 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | -0.083 millimeter for mercury (mmHg) | Standard Deviation 7.421 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | -0.068 millimeter for mercury (mmHg) | Standard Deviation 9.633 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | -1.16 millimeter for mercury (mmHg) | Standard Deviation 11.114 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | 0.013 millimeter for mercury (mmHg) | Standard Deviation 9.733 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | -0.298 millimeter for mercury (mmHg) | Standard Deviation 11.521 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 70.343 millimeter for mercury (mmHg) | Standard Deviation 10.394 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | 0.17 millimeter for mercury (mmHg) | Standard Deviation 10.312 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -0.545 millimeter for mercury (mmHg) | Standard Deviation 11.212 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | -2.96 millimeter for mercury (mmHg) | Standard Deviation 9.199 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | -0.738 millimeter for mercury (mmHg) | Standard Deviation 10.534 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | -2.387 millimeter for mercury (mmHg) | Standard Deviation 10.51 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | -0.094 millimeter for mercury (mmHg) | Standard Deviation 10.086 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Follow-up | -0.172 millimeter for mercury (mmHg) | Standard Deviation 10.211 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 60 | -0.575 millimeter for mercury (mmHg) | Standard Deviation 10.427 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 14 | -0.625 millimeter for mercury (mmHg) | Standard Deviation 9.41 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 30 | -1.163 millimeter for mercury (mmHg) | Standard Deviation 9.622 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 90 | -0.877 millimeter for mercury (mmHg) | Standard Deviation 11.327 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Day 7 | -1.166 millimeter for mercury (mmHg) | Standard Deviation 8.964 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Premature discontinuation | -0.083 millimeter for mercury (mmHg) | Standard Deviation 10.113 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Diastolic Blood Pressure at Specified Visits | Baseline | 71.145 millimeter for mercury (mmHg) | Standard Deviation 9.809 |
Other Pre-specified
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)
Population: Participants in SAF with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | -2.278 Beats per minute (Beats/min) | Standard Deviation 15.909 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Day 7 | -0.8 Beats per minute (Beats/min) | Standard Deviation 10.751 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Day 30 | 0.294 Beats per minute (Beats/min) | Standard Deviation 13.61 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Day 60 | 0.297 Beats per minute (Beats/min) | Standard Deviation 13.033 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -0.189 Beats per minute (Beats/min) | Standard Deviation 12.289 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Baseline | 74.957 Beats per minute (Beats/min) | Standard Deviation 13.813 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Day 14 | -3.109 Beats per minute (Beats/min) | Standard Deviation 15.101 |
| Eplerenone (INSPRA®) | Change From Baseline in Heart Rate at Specified Visits | Follow-up | -1.281 Beats per minute (Beats/min) | Standard Deviation 13.789 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Baseline | 73.369 Beats per minute (Beats/min) | Standard Deviation 13.396 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 60 | -0.975 Beats per minute (Beats/min) | Standard Deviation 14.953 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 7 | 1.073 Beats per minute (Beats/min) | Standard Deviation 13.5 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Follow-up | -2.057 Beats per minute (Beats/min) | Standard Deviation 13.982 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | -1.424 Beats per minute (Beats/min) | Standard Deviation 15.587 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 14 | 0.599 Beats per minute (Beats/min) | Standard Deviation 16.387 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -1.647 Beats per minute (Beats/min) | Standard Deviation 13.001 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 30 | 1.064 Beats per minute (Beats/min) | Standard Deviation 14.128 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 60 | -1.741 Beats per minute (Beats/min) | Standard Deviation 10.86 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 14 | 1.842 Beats per minute (Beats/min) | Standard Deviation 14.988 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Baseline | 72.681 Beats per minute (Beats/min) | Standard Deviation 12.623 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 7 | -0.63 Beats per minute (Beats/min) | Standard Deviation 11.696 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -2.89 Beats per minute (Beats/min) | Standard Deviation 12.034 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 30 | 0.435 Beats per minute (Beats/min) | Standard Deviation 13.63 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | -0.222 Beats per minute (Beats/min) | Standard Deviation 7.591 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Heart Rate at Specified Visits | Follow-up | -0.626 Beats per minute (Beats/min) | Standard Deviation 14.196 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 60 | -2.318 Beats per minute (Beats/min) | Standard Deviation 14.225 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Baseline | 74.184 Beats per minute (Beats/min) | Standard Deviation 12.369 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 7 | -0.719 Beats per minute (Beats/min) | Standard Deviation 10.77 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 14 | -1.324 Beats per minute (Beats/min) | Standard Deviation 13.666 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 30 | -0.349 Beats per minute (Beats/min) | Standard Deviation 12.636 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Follow-up | -1.326 Beats per minute (Beats/min) | Standard Deviation 15.488 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -2.212 Beats per minute (Beats/min) | Standard Deviation 12.041 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | 1.101 Beats per minute (Beats/min) | Standard Deviation 10.22 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 60 | 0.192 Beats per minute (Beats/min) | Standard Deviation 13.377 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 30 | -0.802 Beats per minute (Beats/min) | Standard Deviation 11.311 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 14 | 0.423 Beats per minute (Beats/min) | Standard Deviation 11.247 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -0.71 Beats per minute (Beats/min) | Standard Deviation 13.777 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 7 | -0.548 Beats per minute (Beats/min) | Standard Deviation 11.144 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Follow-up | 0.834 Beats per minute (Beats/min) | Standard Deviation 14.159 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | 4.733 Beats per minute (Beats/min) | Standard Deviation 13.646 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Baseline | 73.852 Beats per minute (Beats/min) | Standard Deviation 11.999 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Premature discontinuation | -2.072 Beats per minute (Beats/min) | Standard Deviation 19.731 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Baseline | 74.329 Beats per minute (Beats/min) | Standard Deviation 13.187 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 14 | -3.969 Beats per minute (Beats/min) | Standard Deviation 13.715 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 30 | -1.633 Beats per minute (Beats/min) | Standard Deviation 12.719 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Follow-up | -1.317 Beats per minute (Beats/min) | Standard Deviation 14.636 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 60 | -1.608 Beats per minute (Beats/min) | Standard Deviation 13.828 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 90 | -1.145 Beats per minute (Beats/min) | Standard Deviation 14.284 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Heart Rate at Specified Visits | Day 7 | -1.176 Beats per minute (Beats/min) | Standard Deviation 13.398 |
Other Pre-specified
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)
Population: Participants in SAF with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.307 millimoles per liter (mmol/L) | Standard Deviation 0.609 |
| Eplerenone (INSPRA®) | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.057 millimoles per liter (mmol/L) | Standard Deviation 0.608 |
| Eplerenone (INSPRA®) | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.159 millimoles per liter (mmol/L) | Standard Deviation 0.495 |
| Eplerenone (INSPRA®) | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.117 millimoles per liter (mmol/L) | Standard Deviation 0.621 |
| Eplerenone (INSPRA®) | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.179 millimoles per liter (mmol/L) | Standard Deviation 0.589 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.135 millimoles per liter (mmol/L) | Standard Deviation 0.573 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.184 millimoles per liter (mmol/L) | Standard Deviation 0.574 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.081 millimoles per liter (mmol/L) | Standard Deviation 0.501 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.226 millimoles per liter (mmol/L) | Standard Deviation 0.694 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.091 millimoles per liter (mmol/L) | Standard Deviation 0.568 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.075 millimoles per liter (mmol/L) | Standard Deviation 0.523 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.153 millimoles per liter (mmol/L) | Standard Deviation 0.516 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.054 millimoles per liter (mmol/L) | Standard Deviation 0.623 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.131 millimoles per liter (mmol/L) | Standard Deviation 0.566 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.211 millimoles per liter (mmol/L) | Standard Deviation 0.541 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.171 millimoles per liter (mmol/L) | Standard Deviation 0.54 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.174 millimoles per liter (mmol/L) | Standard Deviation 0.443 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.085 millimoles per liter (mmol/L) | Standard Deviation 0.475 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.164 millimoles per liter (mmol/L) | Standard Deviation 0.579 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.572 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.275 millimoles per liter (mmol/L) | Standard Deviation 0.58 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.131 millimoles per liter (mmol/L) | Standard Deviation 0.506 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.175 millimoles per liter (mmol/L) | Standard Deviation 0.559 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.21 millimoles per liter (mmol/L) | Standard Deviation 0.592 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.274 millimoles per liter (mmol/L) | Standard Deviation 0.522 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Baseline | 4.117 millimoles per liter (mmol/L) | Standard Deviation 0.506 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 90 | 0.245 millimoles per liter (mmol/L) | Standard Deviation 0.574 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 30 | 0.193 millimoles per liter (mmol/L) | Standard Deviation 0.556 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Follow-up | 0.036 millimoles per liter (mmol/L) | Standard Deviation 0.556 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Serum Potassium at Specified Visits | Day 60 | 0.216 millimoles per liter (mmol/L) | Standard Deviation 0.547 |
Other Pre-specified
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)
Population: Participants in SAF with valid data at specified visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 120.554 millimeter of mercury (mmHg) | Standard Deviation 18.706 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | -0.541 millimeter of mercury (mmHg) | Standard Deviation 13.894 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | -3.442 millimeter of mercury (mmHg) | Standard Deviation 14.258 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | 0.067 millimeter of mercury (mmHg) | Standard Deviation 15.312 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | 0.684 millimeter of mercury (mmHg) | Standard Deviation 16.315 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | -0.967 millimeter of mercury (mmHg) | Standard Deviation 16.408 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | -2.991 millimeter of mercury (mmHg) | Standard Deviation 16.456 |
| Eplerenone (INSPRA®) | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | 0.188 millimeter of mercury (mmHg) | Standard Deviation 16.751 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | -0.824 millimeter of mercury (mmHg) | Standard Deviation 15.747 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | 2.869 millimeter of mercury (mmHg) | Standard Deviation 15.502 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 119.492 millimeter of mercury (mmHg) | Standard Deviation 16.348 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | -3.178 millimeter of mercury (mmHg) | Standard Deviation 13.72 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | -0.41 millimeter of mercury (mmHg) | Standard Deviation 13.936 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | 0.922 millimeter of mercury (mmHg) | Standard Deviation 15.847 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | -4.488 millimeter of mercury (mmHg) | Standard Deviation 10.31 |
| Finerenone (BAY94-8862) 2.5-5 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | 0.337 millimeter of mercury (mmHg) | Standard Deviation 14.176 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | -2.565 millimeter of mercury (mmHg) | Standard Deviation 12.278 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | 4.142 millimeter of mercury (mmHg) | Standard Deviation 15.001 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | -0.367 millimeter of mercury (mmHg) | Standard Deviation 14.984 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | 1.95 millimeter of mercury (mmHg) | Standard Deviation 16.148 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | -1.249 millimeter of mercury (mmHg) | Standard Deviation 13.659 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | 0.047 millimeter of mercury (mmHg) | Standard Deviation 15.643 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | -2.167 millimeter of mercury (mmHg) | Standard Deviation 19.963 |
| Finerenone (BAY94-8862) 5-10 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 118.498 millimeter of mercury (mmHg) | Standard Deviation 14.355 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | 9.391 millimeter of mercury (mmHg) | Standard Deviation 22.378 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | -0.664 millimeter of mercury (mmHg) | Standard Deviation 15.018 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | -1.811 millimeter of mercury (mmHg) | Standard Deviation 14.462 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 119.087 millimeter of mercury (mmHg) | Standard Deviation 16.677 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | 1.241 millimeter of mercury (mmHg) | Standard Deviation 13.561 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | 0.374 millimeter of mercury (mmHg) | Standard Deviation 14.433 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | -0.928 millimeter of mercury (mmHg) | Standard Deviation 17.953 |
| Finerenone (BAY94-8862) 7.5-15 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | 0.568 millimeter of mercury (mmHg) | Standard Deviation 12.733 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | 2.041 millimeter of mercury (mmHg) | Standard Deviation 16.189 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 116.024 millimeter of mercury (mmHg) | Standard Deviation 16.895 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | 0.981 millimeter of mercury (mmHg) | Standard Deviation 15.525 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | 1.216 millimeter of mercury (mmHg) | Standard Deviation 17.831 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | -2.32 millimeter of mercury (mmHg) | Standard Deviation 11.963 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | 0.162 millimeter of mercury (mmHg) | Standard Deviation 15.416 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | -3.099 millimeter of mercury (mmHg) | Standard Deviation 12.591 |
| Finerenone (BAY94-8862) 10-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | 1.786 millimeter of mercury (mmHg) | Standard Deviation 15.039 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Follow-up | 3.037 millimeter of mercury (mmHg) | Standard Deviation 16.782 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 60 | 0.667 millimeter of mercury (mmHg) | Standard Deviation 14.83 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 14 | -2.906 millimeter of mercury (mmHg) | Standard Deviation 15.406 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 30 | 0.899 millimeter of mercury (mmHg) | Standard Deviation 14.608 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 90 | 0.956 millimeter of mercury (mmHg) | Standard Deviation 15.743 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Day 7 | -0.546 millimeter of mercury (mmHg) | Standard Deviation 13.498 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Premature discontinuation | -0.028 millimeter of mercury (mmHg) | Standard Deviation 15.42 |
| Finerenone (BAY94-8862) 15-20 mg OD | Change From Baseline in Systolic Blood Pressure at Specified Visits | Baseline | 116.941 millimeter of mercury (mmHg) | Standard Deviation 16.548 |