Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 28, 2005
December 19, 2007
June 2004
February 2007   (final data collection date for primary outcome measure)
Effectiveness of RSD1235 [ Time Frame: 90 minutes post infusion ]
Not Provided
Complete list of historical versions of study NCT00125320 on ClinicalTrials.gov Archive Site
Proportion of patients in sinus rhythm at 90 minutes [ Time Frame: Time from first exposure to conversion to sinus rhythm ]
Not Provided
Not Provided
Not Provided
 
Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
Drug: RSD1235
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable Class IV heart failure
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Denmark,   India,   Poland
 
NCT00125320
1235-0104
Yes
Not Provided
Astellas Pharma Inc
  • Astellas Pharma US, Inc.
  • Cardiome Pharma
Study Director: Medical Monitor Astellas Pharma US, Inc.
Astellas Pharma Inc
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP