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

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. Identifier: NCT00125320
Recruitment Status : Completed
First Posted : August 1, 2005
Last Update Posted : December 24, 2007
Astellas Pharma US, Inc.
Cardiome Pharma
Information provided by:
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Drug: RSD1235 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable Class IV heart failure

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 identifier (NCT number): NCT00125320

United States, Florida
Fort Lauderdale, Florida, United States, 33308
United States, Georgia
Atlanta, Georgia, United States
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
Aalborg, DK, Denmark, 9000
Hellerup, DK, Denmark, 2900
Odense C, DK, Denmark, 5000
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
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
Study Director: Medical Monitor Astellas Pharma US, Inc.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00125320     History of Changes
Other Study ID Numbers: 1235-0104
First Posted: August 1, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007

Keywords provided by Astellas Pharma Inc:

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