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

This study has been completed.
Information provided by:
Cardiome Pharma Identifier:
First received: December 20, 2005
Last updated: December 17, 2008
Last verified: December 2008
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Cardiome Pharma:

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

Enrollment: 221
Study Start Date: December 2005
Study Completion Date: August 2006
Arms Assigned Interventions
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00267930

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
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
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
Study Director: Greg Beatch, PhD Cardiome Pharma
  More Information

Additional Information:
Responsible Party: Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp. Identifier: NCT00267930     History of Changes
Other Study ID Numbers: 1235-SR-1005
Study First Received: December 20, 2005
Last Updated: December 17, 2008

Keywords provided by Cardiome Pharma:

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes processed this record on August 16, 2017