Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
NCT ID: NCT00267930
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
221 participants
INTERVENTIONAL
2005-12-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
Placebo comparator
2
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
Vernakalant (oral)
3
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
Vernakalant (oral)
Interventions
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Vernakalant (oral)
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have adequate anticoagulant therapy
Exclusion Criteria
* Subjects may not have uncorrected electrolyte imbalance
18 Years
85 Years
ALL
No
Sponsors
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Advanz Pharma
INDUSTRY
Responsible Party
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Cardiome Pharma Corp.
Principal Investigators
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Greg Beatch, PhD
Role: STUDY_DIRECTOR
Advanz Pharma
Locations
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The Heart Center, P.C.
Huntsville, Alabama, United States
Cardiovascular Consultants Medical Group, Inc.
Walnut Creek, California, United States
Penn State Heart & Vascular Institute
Hershey, Pennsylvania, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Foothills Hospital
Calgary, Alberta, Canada
Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu
Montreal, Quebec, Canada
Aalborg Sygehus Syd
Aalborg, , Denmark
Aarhus Sygehus Kardiologisk Afd. A
Aarhus, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
Frederiksberg, , Denmark
KAS Gentofte Kardiologisk Afdeling
Hellerup, , Denmark
KAS Herlev
Herlev, , Denmark
Sygehus Vendsyssel Hjorring
Hjørring, , Denmark
Medicinsk Afdeling Kolding Sygehus
Kolding, , Denmark
Roskilde Amts Sygehus Koge
Køge, , 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
Countries
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Related Links
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Related Info
Other Identifiers
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1235-SR-1005
Identifier Type: -
Identifier Source: org_study_id