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Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery

This study has been completed.
Sponsor:
Collaborators:
Astellas Pharma US, Inc.
Cardiome Pharma
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00125320
First received: July 28, 2005
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

The purpose of this study is to demonstrate the safety and efficacy of RSD1235 compared to placebo in the conversion of atrial arrhythmia to sinus rhythm in subjects following valvular and/or coronary artery bypass graft surgery.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Study of the Conversion Efficacy and Safety of Repeated Intravenous Doses of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter Following Valvular and/or Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Effectiveness of RSD1235 [ Time Frame: 90 minutes post infusion ]

Secondary Outcome Measures:
  • Proportion of patients in sinus rhythm at 90 minutes [ Time Frame: Time from first exposure to conversion to sinus rhythm ]

Enrollment: 190
Study Start Date: June 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

This multi-national, multi-center study is a double blind, randomized, placebo-controlled trial with 2 parallel treatment arms (1 active, 1 placebo) to assess the conversion efficacy and safety of 2 intravenous doses of RSD1235 in subjects with atrial fibrillation or atrial flutter following valvular and/or coronary artery bypass graft (CABG) surgery.

  Eligibility

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

Inclusion Criteria:

  • Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery

Exclusion Criteria:

  • Unstable Class IV heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125320

Locations
United States, Florida
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Atlanta, Georgia, United States
Argentina
Buenos Aires, Argentina
La Plata, Argentina
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada, H2W 1T8
Denmark
Aalborg, DK, Denmark, 9000
Hellerup, DK, Denmark, 2900
Odense C, DK, Denmark, 5000
India
Bangalore, India, 562 158
Chennai, India, 600 037
Hyderabaad, India, 500 001
Kerala, India, 682 026
Mohali, India, 160 062
Mumbai, India, 400 051
New Delhi, India, 110 025
Poland
Katowice, Poland, 40-635
Krakow, Poland, 31-202
Lodz, Poland, 91-425
Warsaw, Poland
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Cardiome Pharma
Investigators
Study Director: Medical Monitor 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):

ClinicalTrials.gov Identifier: NCT00125320     History of Changes
Other Study ID Numbers: 1235-0104
Study First Received: July 28, 2005
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Treatment

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

ClinicalTrials.gov processed this record on May 23, 2013