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Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation (ACT 4)

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. Identifier: NCT00281554
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : April 3, 2008
Cardiome Pharma
Information provided by:
Astellas Pharma Inc

Brief Summary:
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: RSD1235 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation
Study Start Date : October 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: RSD1235
Other Names:
  • vernakalant
  • Kynapid

Primary Outcome Measures :
  1. Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute [ Time Frame: Infusion plus 1.5 hours ]

Secondary Outcome Measures :
  1. Evaluate safety [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject must have symptomatic AF
  • Subject must have adequate anticoagulant therapy

Exclusion Criteria:

  • Subject may not have Class IV congestive heart failure.
  • Subject may not have uncorrected electrolyte imbalance.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00281554

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Sponsors and Collaborators
Astellas Pharma Inc
Cardiome Pharma
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Study Director: Use Central Contact Astellas Pharma US, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc. Identifier: NCT00281554     History of Changes
Other Study ID Numbers: 05-7-012
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: April 2008
Keywords provided by Astellas Pharma Inc:
Investigational Therapies
Atrial Fibrillation
Treatment Efficacy
Treatment Effectiveness
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes