Response to RSD1235 Compared to Placebo in Subjects With Atrial Arrhythmia After Heart Surgery
NCT00125320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190
Last updated 2007-12-24
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.
Conditions
- Atrial Fibrillation
- Atrial Flutter
Interventions
- DRUG
-
RSD1235
Sponsors & Collaborators
-
Astellas Pharma US, Inc.
collaborator INDUSTRY -
Advanz Pharma
collaborator INDUSTRY -
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Astellas Pharma US, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-06-30
- Primary Completion
- 2007-02-28
- Completion
- 2007-02-28
Countries
- United States
- Argentina
- Canada
- Denmark
- India
- Poland
Study Locations
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