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

This study has been completed.
Sponsor:
Information provided by:
Cardiome Pharma
ClinicalTrials.gov Identifier:
NCT00267930
First received: December 20, 2005
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recurrence of AF/AFL or withdrawal [ Time Frame: Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing ] [ Designated as safety issue: No ]
  • Improvement in AF symptoms [ Time Frame: Time to improvement in AF symptoms within Day 28 of dosing ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: December 20, 2005
Last Updated: December 17, 2008
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 of the Russian Federation
Sweden: Medical Products Agency
Ukraine: Ministry of Health

Keywords provided by Cardiome Pharma:
AFib
AF

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

ClinicalTrials.gov processed this record on May 23, 2013