To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
482
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Tablet; Once daily in the morning; Oral
Tablet; 40mg unit; 80mg once daily in the morning; Oral
PART A: Change in body weight
Time frame: Compare Day 30 (End of part A) with Day 1 (Start of part A)
PART A: Change in serum creatinine
Time frame: Compare Day 30 (End of part A) with Day 1 (Start of part A)
PART B: Change in body weight
Time frame: Compare Day 60 (End of part B) with Day 30 (Start of part B)
PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratio
Time frame: Compare Day 60 (End of part B) with Day 30 (Start of part B)
Incidence of Treatment-emergent adverse event (including Serious adverse event)
Time frame: From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60)
Change in augmentation index
Time frame: Up to 60 days
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Tablet; Once daily in the morning; Oral
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...and 56 more locations