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Sponsored by: |
Cardiome Pharma |
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Information provided by: | Cardiome Pharma |
ClinicalTrials.gov Identifier: | NCT00267930 |
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
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: Vernakalant (oral) Drug: Placebo comparator |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF |
Enrollment: | 221 |
Study Start Date: | December 2005 |
Study Completion Date: | August 2006 |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
|
Drug: Placebo comparator |
2: Experimental
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
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Drug: Vernakalant (oral) |
3: Experimental
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
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Drug: Vernakalant (oral) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (partial list):
Exclusion Criteria (partial list):
United States, Alabama | |
The Heart Center, P.C. | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
Cardiovascular Consultants Medical Group, Inc. | |
Walnut Creek, California, United States, 94598 | |
United States, Pennsylvania | |
Penn State Heart & Vascular Institute | |
Hershey, Pennsylvania, United States, 17033 | |
United States, Wisconsin | |
Marshfield Clinic | |
Marshfield, Wisconsin, United States, 54449 | |
Canada, Alberta | |
Foothills Hospital | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, Quebec | |
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu | |
Montréal, Quebec, Canada, H2W 1T8 | |
Denmark | |
Bispebjerg Hospital | |
Kobenhavn, Denmark | |
KAS Gentofte Kardiologisk Afdeling | |
Hellerup, Denmark | |
Medicinsk Afdeling Kolding Sygehus | |
Kolding, Denmark, 6000 | |
Aalborg Sygehus Syd | |
Aalborg, Denmark, 9100 | |
Aarhus Sygehus Kardiologisk Afd. A | |
Aarhus, Denmark, 8000 | |
Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital | |
Frederiksberg, Denmark, 2000 | |
Roskilde Amts Sygehus Koge | |
Koge, Denmark, 4600 | |
Sygehus Vendsyssel Hjorring | |
Hjorring, Denmark, 9800 | |
KAS Herlev | |
Herlev, Denmark, 2730 | |
Netherlands | |
Catharina Ziekenhuis | |
Eindhoven, Netherlands | |
University Medical Center Groningen (UMCG) | |
Groningen, Netherlands | |
Stichting Sint Antonius Ziekenhuis | |
Nieuwegein, Netherlands | |
Trial sectie Cardiologie | |
Heerlen, Netherlands | |
Medisch Spectrum Twente | |
Enschede, Netherlands | |
Reinier de Graaf Gasthuis | |
Delft, Netherlands | |
Academisch Ziekenhuis Maastricht | |
Maastricht, Netherlands |
Study Director: | Greg Beatch, PhD | Cardiome Pharma |
Responsible Party: | Cardiome Pharma Corp. ( Gregory Beatch, Ph.D., Vice President, Scientific Affairs ) |
Study ID Numbers: | 1235-SR-1005 |
Study First Received: | December 20, 2005 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00267930 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Bulgaria: Ministry of Health; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Hungary: National Institute of Pharmacy; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Russia: Ministry of Health and Social Development of the Russian Federation; Sweden: Medical Products Agency; Ukraine: Ministry of Health |
AFib AF |
Heart Diseases Atrial Fibrillation Recurrence Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |