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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

December 20, 2005
December 17, 2008
December 2005
Not Provided
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 ]
All subjects who are exposed to the investigational medication will be evaluated for safety.
Complete list of historical versions of study NCT00267930 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Recurrence of AF/AFL or withdrawal;
  • Improvement in AF symptoms.
Not Provided
Not Provided
 
Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter Recurrence
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atrial Fibrillation
  • Drug: Vernakalant (oral)
    Other Name: RSD1235-SR
  • Drug: Placebo comparator
  • Placebo Comparator: 1
    Tier 1: 1 placebo capsule b.i.d Tier 2: 2 placebo capsules b.i.d
    Intervention: Drug: Placebo comparator
  • Experimental: 2
    Tier 1: Vernakalant (oral) 1 x 300 mg capsule b.i.d
    Intervention: Drug: Vernakalant (oral)
  • Experimental: 3
    Tier 2: Vernakalant (oral) 2 x 300 mg (600 mg) b.i.d
    Intervention: Drug: Vernakalant (oral)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
August 2006
Not Provided

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Netherlands
 
NCT00267930
1235-SR-1005
No
Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp.
Cardiome Pharma
Not Provided
Study Director: Greg Beatch, PhD Cardiome Pharma
Cardiome Pharma
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP