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

This study has been completed.
Sponsor:
Collaborator:
Cardiome Pharma
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00281554
First received: January 24, 2006
Last updated: April 1, 2008
Last verified: April 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate safety [ Time Frame: End of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Astellas Pharma Inc

Additional 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
Study First Received: January 24, 2006
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
South Africa: Medicines Control Council

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

ClinicalTrials.gov processed this record on September 22, 2014