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To determine the effect of our compound (BMS-919373) on electrical activity of the heart using pacemakers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: BMS-919373 | Experimental | BMS-919373 oral Solution/tablet single dose for one day |
|
| Arm B: Sotalol | Active Comparator | Sotalol oral Tablet single dose for one day |
|
| Arm C: Placebo for BMS-919373 | Placebo Comparator | Oral solution/tablet one single dose for one day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-919373 | Drug |
|
| |
| Sotalol |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of BMS-919373 on Atrial effective refractory period (AERP) in subjects with a dual chamber pacemaker | At 0.5, 1, 2, and 4 hours following study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The safety assessments will be based on Adverse event reports, vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests | At 1, 2, and 4 hours following study drug administration | |
| Safety assessments based on Ventricular Effective Refractory Period (VERP) and change from baseline |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
Exclusion Criteria
- Patients with a history of Atrial Fibrillation (AF) that is either:.
i) Permanent (i.e. patients are only in AF and never in sinus rhythm) or.
ii) Persistent (i.e. patients who's episodes of AF are longer than 7 days and require medical intervention, such as electrical or medical cardioversion, to return to sinus rhythm), are excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Austin | Texas | 78705 | United States | ||
| The University Of Calgary |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting |
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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 |
|---|---|
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| Placebo for BMS-919373 | Drug |
|
| At 2 hour following study drug administration |
| Safety assessments based on Atrioventricular interval (AVI) and change from baseline | At 1, 2, and 4 hours following study drug administration |
| Safety assessments based on Wenckebach cycle length (WCL) and change from baseline | At 1, 2, and 4 hours following study drug administration |
| Safety assessments based on Intra-atrial conduction time (IACT) and change from baseline | At 1, 2, and 4 hours following study drug administration |
| Calgary |
| Alberta |
| T2N 4N1 |
| Canada |
| University Of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Local Institution - 0001 | Toronto | Ontario | M5B 1W8 | Canada |
| Local Institution - 0002 | Montreal | Quebec | H1T 1C8 | Canada |
| Local Institution | Montreal | Quebec | H2W 1T8 | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |