Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

This study has been completed.
Sponsor:
Collaborator:
Cardiome Pharma
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00115791
First received: June 26, 2005
Last updated: March 29, 2008
Last verified: March 2008
  Purpose

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.


Condition Intervention Phase
Atrial Flutter
Atrial Fibrillation
Drug: RSD1235
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm [ Time Frame: Infusion plus 1.5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the time taken from exposure to first treatment to first conversion to sinus rhythm [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: June 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RSD1235
IV
Other Names:
  • vernakalant
  • Kynapid
Placebo Comparator: 2 Drug: placebo
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion Criteria:

  • Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
  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: NCT00115791

  Show 54 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: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00115791     History of Changes
Other Study ID Numbers: 04-7-010, Cardiome 1235-0504
Study First Received: June 26, 2005
Last Updated: March 29, 2008
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Pública de Chile
Canada: Health Canada
Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Astellas Pharma Inc:
Atrial Flutters
Atrial Fibrillations
RSD1235

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

ClinicalTrials.gov processed this record on July 28, 2014