A Phase 1 interventional study of Vericiguat (BAY1021189) and Placebo in Coronary Artery Disease, sponsored by Bayer. Completed at 6 sites in Germany. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-29.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 36 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Patients with stable CAD defined by
Exclusion Criteria:
Co-administration of vericiguat and nitroglycerin
Drug: Vericiguat (BAY1021189) · Drug: Nitroglycerin
Aministration of matching placebo and nitroglycerin.
Drug: Placebo · Drug: Nitroglycerin
Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets
Placebo for 14 +/-3 days given as 1 or 2 tablets \[o.d.\].
0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat \[trough\] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat \[peak\] or placebo) on day 13, day 27 and day 41
Number of participants with adverse events as measure of safety and tolerability
Time frame: approximately 1 year
Blood pressure
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Time frame: approximately 1 year
Heart rate
Regular measurement of heart rate (bpm) in supine, sitting and standing position.
Time frame: approximately 1 year
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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