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

Phase 3

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation

• Registration Number: NCT00125320
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-07-28
• Study First Submitted QC: 2005-07-28
• Study First Posted: 2005-08-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

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

Exclusion Criteria

• Unstable Class IV heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of RSD1235	90 minutes post infusion

Secondary Outcome Measures

Name	Time	Method
Proportion of patients in sinus rhythm at 90 minutes	Time from first exposure to conversion to sinus rhythm