Status:

COMPLETED

Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

Lead Sponsor:

Astellas Pharma Inc

Collaborating Sponsors:

Advanz Pharma

Conditions:

Atrial Flutter

Atrial Fibrillation

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.

Eligibility Criteria

Inclusion

  • Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion

  • Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2005

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT00115791

Start Date

June 1 2004

End Date

June 1 2005

Last Update

April 1 2008

Active Locations (54)

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Page 1 of 14 (54 locations)

1

Investigative Site

Birmingham, Alabama, United States, 35213

2

Investigative Site

Huntsville, Alabama, United States, 35801

3

Investigative Site

Gainesville, Florida, United States, 32610

4

Investigative Site

Orlando, Florida, United States, 32803