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Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence

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ClinicalTrials.gov Identifier: NCT00267930
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Cardiome Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Vernakalant (oral) Drug: Placebo comparator Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : December 2005
Actual Study Completion Date : August 2006

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
 Drug: Placebo comparator
Experimental: 2
Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
 Drug: Vernakalant (oral)
Other Name: RSD1235-SR
Experimental: 3
Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
 Drug: Vernakalant (oral)
Other Name: RSD1235-SR


Outcome Measures
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Primary Outcome Measures :
  1. All subjects who were exposed to the investigational medication were evaluated for safety. [ Time Frame: Subjects were assessed for safety within Day 58 of dosing ]

Secondary Outcome Measures :
  1. Recurrence of AF/AFL or withdrawal [ Time Frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing ]
  2. Improvement in AF symptoms [ Time Frame: Time to improvement in AF symptoms within Day 28 of dosing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (partial list):

  • Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration
  • Subjects must have adequate anticoagulant therapy

Exclusion Criteria (partial list):

  • Subjects may not have Class III or Class IV congestive heart failure
  • Subjects may not have uncorrected electrolyte imbalance
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267930


Locations
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
Aalborg Sygehus Syd
Aalborg, Denmark, 9100
Aarhus Sygehus Kardiologisk Afd. A
Aarhus, Denmark, 8000
Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital
Frederiksberg, Denmark, 2000
KAS Gentofte Kardiologisk Afdeling
Hellerup, Denmark
KAS Herlev
Herlev, Denmark, 2730
Sygehus Vendsyssel Hjorring
Hjorring, Denmark, 9800
Bispebjerg Hospital
Kobenhavn, Denmark
Roskilde Amts Sygehus Koge
Koge, Denmark, 4600
Medicinsk Afdeling Kolding Sygehus
Kolding, Denmark, 6000
Netherlands
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
Sponsors and Collaborators
Cardiome Pharma
Investigators
Study Director: Greg Beatch, PhD Cardiome Pharma
More Information
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Responsible Party: Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00267930     History of Changes
Other Study ID Numbers: 1235-SR-1005
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008

Keywords provided by Cardiome Pharma:
AFib
AF

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Atrial Flutter
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes