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

This study has been completed.
Astellas Pharma US, Inc.
Cardiome Pharma
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 28, 2005
Last updated: December 19, 2007
Last verified: December 2007
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
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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 identifier: 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.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00125320     History of Changes
Other Study ID Numbers: 1235-0104
Study First Received: July 28, 2005
Last Updated: December 19, 2007

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on September 21, 2017