The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objectives are the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily). Each dose group consists of 9 patients treated with verum and 3 patients treated with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
49
5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks
10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks
25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks
50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks
The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
Unnamed facility
Copenhagen, Denmark
Unnamed facility
Copenhagen Ø, Denmark
Unnamed facility
Hellerup, Denmark
Unnamed facility
Herlev, Denmark
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Düsseldorf, North Rhine-Westphalia, Germany
Unnamed facility
Erfurt, Thuringia, Germany
Unnamed facility
Berlin, Germany
Unnamed facility
Bergamo, Lombardy, Italy
Unnamed facility
Brescia, Lombardy, Italy
Number of participants with adverse events
Time frame: Up to 20 days
Number of participants with serious adverse events
Time frame: Up to 20 days
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