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This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d |
|
| 2 | Experimental | Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d |
|
| 3 | Experimental | Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vernakalant (oral) | Drug |
|
| |
| Placebo comparator |
| Measure | Description | Time Frame |
|---|---|---|
| All subjects who were exposed to the investigational medication were evaluated for safety. | Subjects were assessed for safety within Day 58 of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of AF/AFL or withdrawal | Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing | |
| Improvement in AF symptoms | Time to improvement in AF symptoms within Day 28 of dosing |
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Inclusion Criteria (partial list):
Exclusion Criteria (partial list):
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| Name | Affiliation | Role |
|---|---|---|
| Greg Beatch, PhD | Advanz Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Center, P.C. | Huntsville | Alabama | 35801 | United States | ||
| Cardiovascular Consultants Medical Group, Inc. |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Drug |
|
| Walnut Creek |
| California |
| 94598 |
| United States |
| Penn State Heart & Vascular Institute | Hershey | Pennsylvania | 17033 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Foothills Hospital | Calgary | Alberta | T2N 2T9 | Canada |
| Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu | Montreal | Quebec | H2W 1T8 | Canada |
| Aalborg Sygehus Syd | Aalborg | 9100 | Denmark |
| Aarhus Sygehus Kardiologisk Afd. A | Aarhus | 8000 | Denmark |
| Bispebjerg Hospital | Copenhagen | Denmark |
| Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| KAS Gentofte Kardiologisk Afdeling | Hellerup | Denmark |
| KAS Herlev | Herlev | 2730 | Denmark |
| Sygehus Vendsyssel Hjorring | Hjørring | 9800 | Denmark |
| Medicinsk Afdeling Kolding Sygehus | Kolding | 6000 | Denmark |
| Roskilde Amts Sygehus Koge | Køge | 4600 | Denmark |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Medisch Spectrum Twente | Enschede | Netherlands |
| University Medical Center Groningen (UMCG) | Groningen | Netherlands |
| Trial sectie Cardiologie | Heerlen | Netherlands |
| Academisch Ziekenhuis Maastricht | Maastricht | Netherlands |
| Stichting Sint Antonius Ziekenhuis | Nieuwegein | Netherlands |
| 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 |
|---|---|
| C524581 | vernakalant |
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