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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00281554
First Posted: January 25, 2006
Last Update Posted: April 3, 2008
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.
Collaborator:
Cardiome Pharma
Information provided by:
Astellas Pharma Inc
  Purpose
This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Condition Intervention Phase
Atrial Fibrillation Drug: RSD1235 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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:
  • Evaluate safety [ Time Frame: End of study ]

Enrollment: 254
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RSD1235
IV
Other Names:
  • vernakalant
  • Kynapid

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00281554


  Show 40 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Cardiome Pharma
Investigators
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00281554     History of Changes
Other Study ID Numbers: 05-7-012
First Submitted: January 24, 2006
First Posted: January 25, 2006
Last Update Posted: April 3, 2008
Last Verified: April 2008

Keywords provided by Astellas Pharma Inc:
Investigational Therapies
Atrial Fibrillation
Treatment Efficacy
Treatment Effectiveness
Safety
RSD1235

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes