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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125320
• Other study ID #: 1235-0104
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2005
• Last updated: December 19, 2007
• Start date: June 2004
• Est. completion date: February 2007

Study information

• Verified date: December 2007
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable Class IV heart failure

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• RSD1235

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc., Cardiome Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Denmark,  India,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of RSD1235		90 minutes post infusion
Secondary	Proportion of patients in sinus rhythm at 90 minutes		Time from first exposure to conversion to sinus rhythm