A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
One 10 mg BAY94-8862 tablet for duration of 4 weeks
Change of serum potassium
Time frame: 4 weeks
Change in serum magnesium
Time frame: Day 8, Day 15, Day 22, Day 29
Change in blood pressure
Time frame: Day 8, Day 15, Day 22, Day 29
Change in heart rate
Time frame: Day 8, Day 15, Day 22, Day 29
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Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
Placebo tablets for duration of 4 weeks
Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
Unnamed facility
Graz, Styria, Austria
Unnamed facility
Linz, Upper Austria, Austria
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Vienna, Austria
Unnamed facility
Brasschaat, Belgium
Unnamed facility
Bruxelles - Brussel, Belgium
Unnamed facility
Roeselare, Belgium
Unnamed facility
Brno, Czechia
Unnamed facility
Liberec, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
...and 40 more locations