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

Phase 3

Completed

• Conditions: Atrial Flutter; Atrial Fibrillation
• Interventions: Drug: RSD1235; Drug: placebo

• Registration Number: NCT00115791
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2005-06-26
• Study First Submitted QC: 2005-06-26
• Study First Posted: 2005-06-27
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-29
• Last Update Posted: 2008-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RSD1235	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
To demonstrate the efficacy of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm	Infusion plus 1.5 hours

Secondary Outcome Measures

Name	Time	Method
To assess the time taken from exposure to first treatment to first conversion to sinus rhythm	End of study

Trial Locations

Locations (1)

Investigative Site; 🇸🇪 Uppsala, Sweden