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To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration >3 days and <6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Dose 1 | Experimental | K201 |
|
| Dose 2 | Experimental | K201 |
|
| Dose 3 | Experimental | K201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K201 Tablet | Drug | oral tablet, x28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to first documented recurrence of symptomatic AF | 28 days | |
| time to first documented recurrence of symptomatic or asymptomatic AF | 28 days | |
| proportion of subjects in sinus rhythm | Day 28 | |
| number of AF beats | 10 days | |
| time in AF | 10 days | |
| safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Chamberlin, MD | Sequel Pharmaceuticals | Study Director |
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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 |
|---|---|
| C109183 | K201 compound |
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| Placebo Tablet |
| Drug |
oral tablet, x28 days |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |