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Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation (ACT 4)
This study has been completed.
First Received: January 24, 2006   Last Updated: April 1, 2008   History of Changes
Sponsors and Collaborators: Astellas Pharma Inc
Cardiome Pharma
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00281554
  Purpose

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


Condition Intervention Phase
Atrial Fibrillation
 Drug: RSD1235
 Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Atrial Fibrillation
Drug Information available for: RSD 1235
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 3, Multi-Center, Open Label, Safety Study of RSD1235 in Subjects With Atrial Fibrillation

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
1: Experimental Drug: RSD1235
IV

  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
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

Responsible Party: Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers: 05-7-012
Study First Received: January 24, 2006
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00281554     History of Changes
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

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

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

ClinicalTrials.gov processed this record on May 07, 2009



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