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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001444-11 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vericiguat + Nitroglycerin | Experimental | Co-administration of vericiguat and nitroglycerin |
|
| Placebo + Nitroglycerin | Placebo Comparator | Aministration of matching placebo and nitroglycerin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat (BAY1021189) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as measure of safety and tolerability | approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Regular measurement of blood pressure (mmHg) in supine, sitting and standing position. | approximately 1 year |
| Heart rate | Regular measurement of heart rate (bpm) in supine, sitting and standing position. |
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Inclusion Criteria:
Patients with stable CAD defined by
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heidelberg | Baden-Wurttemberg | 69120 | Germany | |||
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.]. |
|
| Nitroglycerin | Drug | 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 |
|
| approximately 1 year |
| Bonn |
| North Rhine-Westphalia |
| 53105 |
| Germany |
| Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| Erfurt | Thuringia | 99084 | Germany |
| Berlin | 13353 | Germany |
| Hamburg | 20251 | Germany |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |