Heart failure due to systemic left ventricular systolic dysfunction
Conditions
Brief summary
Number of participants with treatment emergent adverse events (TEAEs), Change in serum potassium levels from baseline to Day 270± 7 (Visit 6, EoT), Change in systolic blood pressure (SBP) from baseline to Day 270± 7 (Visit 6, EoT), Change in estimated glomerular filtration rate (eGFR) from baseline to Day 270± 7 (Visit 6, EoT)
Detailed description
Change in NT-proBNP from baseline to Day 270± 7 (Visit 6, EoT), Change in key echocardiographic parameters of left ventricular systolic function from baseline to Day 270± 7 (Visit 6, EoT), Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md), Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md), Taste and texture questionnaire of the pediatric formulation
Interventions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events (TEAEs), Change in serum potassium levels from baseline to Day 270± 7 (Visit 6, EoT), Change in systolic blood pressure (SBP) from baseline to Day 270± 7 (Visit 6, EoT), Change in estimated glomerular filtration rate (eGFR) from baseline to Day 270± 7 (Visit 6, EoT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in NT-proBNP from baseline to Day 270± 7 (Visit 6, EoT), Change in key echocardiographic parameters of left ventricular systolic function from baseline to Day 270± 7 (Visit 6, EoT), Maximum observed finerenone concentration in plasma after multiple doses (Cmax, md), Area under the curve for finerenone concentration in plasma after multiple doses (AUCτ,md), Taste and texture questionnaire of the pediatric formulation | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Finland, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain, Sweden
Outcome results
None listed