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Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion |
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| Cohort B | Experimental | Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion |
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| Cohort C | Experimental | Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion |
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| Cohort D | Experimental | Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion |
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| Cohort E | Experimental | Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecadenoson | Drug | Tecadenoson administered intravenously (i.v.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities | Baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram | Baseline to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CV Therapeutics, Inc. | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23989533 | Derived | Corino VD, Holmqvist F, Mainardi LT, Platonov PG. Beta-blockade and A1-adenosine receptor agonist effects on atrial fibrillatory rate and atrioventricular conduction in patients with atrial fibrillation. Europace. 2014 Apr;16(4):587-94. doi: 10.1093/europace/eut251. Epub 2013 Aug 29. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C118601 | tecadenoson |
| C036604 | esmolol |
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|
| Esmolol | Drug | Esmolol low dose infusion according to manufacturer's instructions |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |