NCT00125320CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 190
- Locations
- 22
- Primary Endpoint
- Effectiveness of RSD1235
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented atrial arrhythmia after valvular and/or coronary artery bypass graft surgery
Exclusion Criteria
- •Unstable Class IV heart failure
Outcomes
Primary Outcomes
Effectiveness of RSD1235
Time Frame: 90 minutes post infusion
Secondary Outcomes
- Proportion of patients in sinus rhythm at 90 minutes(Time from first exposure to conversion to sinus rhythm)
Investigators
Study Sites (22)
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