Study of RSD1235 to Evaluate Safety in Patients With Atrial Fibrillation

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: RSD1235

• Registration Number: NCT00281554
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

This study is designed to determine the safety of RSD1235 in patients with atrial fibrillation.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-01
• Last Update Posted: 2008-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• Subject must have symptomatic AF
• Subject must have adequate anticoagulant therapy

Exclusion Criteria

• Subject may not have Class IV congestive heart failure.
• Subject may not have uncorrected electrolyte imbalance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	RSD1235	-

Primary Outcome Measures

Name	Time	Method
Rate of conversion of atrial fibrillation to sinus rhythm for a minimum of 1 minute	Infusion plus 1.5 hours

Secondary Outcome Measures

Name	Time	Method
Evaluate safety	End of study