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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001287-34 | EudraCT Number |
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This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo and BAY1067197 | Experimental | Patients will get both treatment 1 and 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo (treatment 1) | Drug | Oral administration of placebo tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with occurrence of AV-Block > I° | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile determined by tmax | up to 24 hours | |
| Pharmacokinetic profile determined by t1/2 | up to 22 days | |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groningen | 9700 RB | Netherlands |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| BAY1067197 (treatment 2) |
| Drug |
Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197 |
|
| multiple time points up to 24 hours |
| Blood pressure | multiple time points up to 24 hours |
| Number of participants with adverse events as a measure of safety and tolerability | up to 48 hours |