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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022947-39 | EudraCT Number |
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The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: BMS-914392 | Experimental |
| |
| Treatment B: BMS-914392 | Experimental |
| |
| Treatment C: BMS-914392 | Experimental |
| |
| Treatment D: Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-914392 | Drug | Tablets, Oral, 10 mg, Every Day (QD), 20 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation Burden | At screening (baseline) | |
| Atrial Fibrillation Burden | Prior to randomization to study drug | |
| Atrial Fibrillation Burden | On Day 1 of each cross-over period | |
| Atrial Fibrillation Burden | On Day 8 of each cross-over period | |
| Atrial Fibrillation Burden | On Day 22 of each cross-over period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events and type of adverse events | At Day 1 of each cross-over period | |
| Number of participants with adverse events and type of adverse events | At Day 8 of each cross-over period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastbourne General Hospital | Eastbourne | BN21 2UD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26462707 | Derived | Podd SJ, Freemantle N, Furniss SS, Sulke N. First clinical trial of specific IKACh blocker shows no reduction in atrial fibrillation burden in patients with paroxysmal atrial fibrillation: pacemaker assessment of BMS 914392 in patients with paroxysmal atrial fibrillation. Europace. 2016 Mar;18(3):340-6. doi: 10.1093/europace/euv263. Epub 2015 Oct 12. |
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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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| BMS-914392 |
| Drug |
Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days |
|
| BMS-914392 | Drug | Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days |
|
| Placebo | Drug | Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days |
|
| Number of participants with adverse events and type of adverse events | At Day 22 of each cross-over period |
| Number of Atrial fibrillation (AF) episodes | At Day 1 of each cross-over period |
| Number of AF episodes | At Day 8 of each cross-over period |
| Number of AF episodes | At Day 22 of each cross-over period |
| Duration of AF episodes | At Day 1 of each cross-over period |
| Duration of AF episodes | At Day 8 of each cross-over period |
| Duration of AF episodes | At Day 22 of each cross-over period |
| Heart Rate | At Day 1 of each cross-over period |
| Heart Rate | At Day 8 of each cross-over period |
| Heart Rate | At Day 22 of each cross-over period |
| Severity of AF (SAF) scale score at the end of each study period | At Day 1 of each cross-over period |
| Severity of AF (SAF) scale score at the end of each study period | At Day 8 of each cross-over period |
| Severity of AF (SAF) scale score at the end of each study period | At Day 22 of each cross-over period |
| Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) | At Day 1 of each cross-over period |
| Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) | At Day 8 of each cross-over period |
| Electrocardiogram (ECG) intervals (PR, QRS, RR, QT, QTc) | At Day 22 of each cross-over period |
| BMS-914392 plasma concentrations and exposures during each study period | At Days 1, 8 and 22 of each cross-over period |
| D013568 |
| Pathological Conditions, Signs and Symptoms |