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Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma US, Inc. Cardiome Pharma |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00125320 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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) |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Fort Lauderdale, Florida, United States, 33308 | |
United States, Georgia | |
Atlanta, Georgia, United States | |
Argentina | |
Buenos Aires, 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, DK | |
Hellerup, DK, Denmark, 2900 | |
Odense C, DK, Denmark, 5000 | |
Aalborg, DK, Denmark, 9000 | |
India | |
New Delhi, India, 110 025 | |
Bangalore, India, 562 158 | |
Kerala, India, 682 026 | |
Hyderabaad, India, 500 001 | |
Mohali, India, 160 062 | |
Mumbai, India, 400 051 | |
Chennai, India, 600 037 | |
Poland | |
Krakow, Poland, 31-202 | |
Lodz, Poland, 91-425 | |
Katowice, Poland, 40-635 | |
Warsaw, Poland |
Study Director: | Medical Monitor | Astellas Pharma US, Inc. |
Study ID Numbers: | 1235-0104 |
Study First Received: | July 28, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00125320 |
Health Authority: | United States: Food and Drug Administration |
Treatment |
Heart Diseases Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |