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Sponsors and Collaborators: |
Astellas Pharma Inc Cardiome Pharma |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00115791 |
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.
Condition | Intervention | Phase |
---|---|---|
Atrial Flutter Atrial Fibrillation |
Drug: RSD1235 Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase 3, Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Tolerance and Efficacy Study of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter |
Enrollment: | 276 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2005 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: RSD1235
IV
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2: Placebo Comparator |
Drug: placebo
IV
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Use Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry ) |
Study ID Numbers: | 04-7-010, Cardiome 1235-0504 |
Study First Received: | June 26, 2005 |
Last Updated: | March 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00115791 |
Health Authority: | United States: Food and Drug Administration; Sweden: Medical Products Agency; Denmark: Danish Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Instituto de Salud Publica de Chile; Canada: Health Canada; Mexico: National Institute of Public Health, Health Secretariat |
Atrial Flutters Atrial Fibrillations RSD1235 |
Heart Diseases Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |