This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with evidence-based therapy for heart failure (HF) for at least 3 months prior to emergency presentation to hospital using a multi-center, randomized, adaptive, double-blind, double-dummy, comparator-controlled, parallel-group design. Primary objective of the study is to investigate efficacy \[percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Visit 10 (Day 90)\] and safety of different oral doses of BAY94-8862 given once daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
matching placebo
Unnamed facility
Seto, Aichi-ken, Japan
Unnamed facility
Toyota, Aichi-ken, Japan
Unnamed facility
Funabashi, Chiba, Japan
Unnamed facility
Kamogawa, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Chikushino-shi, Fukuoka, Japan
Unnamed facility
Amagasaki, Hyōgo, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Higashiibaraki, Ibaraki, Japan
...and 19 more locations
The percentage of subjects with a relative decrease in N-terminal prohormone B-type natriuretic peptide of more than 30% from baseline to Visit 10
Time frame: From baseline to 90 days
Change in serum potassium
Time frame: From baseline to 90 days
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