Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
Primary Purpose
Atrial Fibrillation, Atrial Flutter
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSD1235
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Treatment
Eligibility Criteria
Inclusion Criteria: Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery Exclusion Criteria: Unstable Class IV heart failure
Sites / Locations
Outcomes
Primary Outcome Measures
Effectiveness of RSD1235
Secondary Outcome Measures
Proportion of patients in sinus rhythm at 90 minutes
Full Information
NCT ID
NCT00125320
First Posted
July 28, 2005
Last Updated
December 19, 2007
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc., Advanz Pharma
1. Study Identification
Unique Protocol Identification Number
NCT00125320
Brief Title
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc., Advanz Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RSD1235
Primary Outcome Measure Information:
Title
Effectiveness of RSD1235
Time Frame
90 minutes post infusion
Secondary Outcome Measure Information:
Title
Proportion of patients in sinus rhythm at 90 minutes
Time Frame
Time from first exposure to conversion to sinus rhythm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery
Exclusion Criteria:
Unstable Class IV heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Buenos Aires
Country
Argentina
City
La Plata
Country
Argentina
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
City
Aalborg
State/Province
DK
ZIP/Postal Code
9000
Country
Denmark
City
Hellerup
State/Province
DK
ZIP/Postal Code
2900
Country
Denmark
City
Odense C
State/Province
DK
ZIP/Postal Code
5000
Country
Denmark
City
Bangalore
ZIP/Postal Code
562 158
Country
India
City
Chennai
ZIP/Postal Code
600 037
Country
India
City
Hyderabaad
ZIP/Postal Code
500 001
Country
India
City
Kerala
ZIP/Postal Code
682 026
Country
India
City
Mohali
ZIP/Postal Code
160 062
Country
India
City
Mumbai
ZIP/Postal Code
400 051
Country
India
City
New Delhi
ZIP/Postal Code
110 025
Country
India
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19948506
Citation
Kowey PR, Dorian P, Mitchell LB, Pratt CM, Roy D, Schwartz PJ, Sadowski J, Sobczyk D, Bochenek A, Toft E; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for the rapid conversion of atrial fibrillation after cardiac surgery: a randomized, double-blind, placebo-controlled trial. Circ Arrhythm Electrophysiol. 2009 Dec;2(6):652-9. doi: 10.1161/CIRCEP.109.870204.
Results Reference
derived
Learn more about this trial
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
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