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The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| K201 | Experimental | intravenous K201 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saline | Drug | intravenous infusion |
| |
| K201 |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects who convert to sinus rhythm | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Chamberlin, MD | Sequel Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen | Denmark | |||||
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| Drug |
intravenous infusion |
|
| Esbjerg |
| Denmark |
| Glostrup Municipality | Denmark |
| Haderslev | Denmark |
| Hellerup | Denmark |
| Herlev | Denmark |
| Hvidovre | Denmark |
| Kolding | Denmark |
| Odense | Denmark |
| Roskilde | Denmark |
| Silkeborg | Denmark |
| Svendborg | Denmark |
| Varde | Denmark |
| Viborg | Denmark |
| Ashkelon | Israel |
| Rehovot | Israel |
| Safed | Israel |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C109183 | K201 compound |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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