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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00267930
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Correvio International Sarl

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
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Sponsors and Collaborators
Correvio International Sarl
Investigators
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Study Director: Greg Beatch, PhD Correvio International Sarl
More Information
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Additional Information:

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Responsible Party: Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp.
ClinicalTrials.gov Identifier: NCT00267930    
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 Correvio International Sarl:
AFib
AF
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Recurrence
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes