Placebo Comparator
Placebo + isosorbite mononitrate
Administration of (vericiguat) matching placebo and isosorbite mononitrate.
Drug :
Placebo + isosorbite mononitrate (ISMN)
ISMN up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration
Placebo for about 14 days, once daily
60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days)
Experimental
Vericiguat + isosorbite mononitrate
Co-administration of vericiguat and isosorbite mononitrate.
Drug :
Vericiguat (BAY1021189) + isosorbite mononitrate
ISMN up-titration with 30 mg / 60 mg, about 7 days each, prior to start of vericiguat administration
Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be up-titrated to 5 mg and to 10 mg:
2.5 mg vericiguat for about 14 days followed by 5 mg vericiguat for about 14 days followed by 10 mg vericiguat for about 14 days
60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days)
|