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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Collaborator: |
Cardiome Pharma |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00989001 |
Purpose
The purpose of this study is to evaluate the safety and efficacy of vernakalant injection in subjects with recent onset (AF > 3 hours to <= 7 days), symptomatic atrial fibrillation and no evidence or history of congestive heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Vernakalant Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3b Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Vernakalant Hydrochloride Injection in Patients With Recent Onset Symptomatic Atrial Fibrillation |
| Estimated Enrollment: | 470 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Vernakalant: Experimental |
Drug: Vernakalant
Injection
|
| Placebo: Placebo Comparator |
Drug: Placebo
Injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Astellas Pharma Global Development | 800-888-7704 ext 5473 | clintrials.info@us.astellas.com |
Show 68 Study Locations| Study Director: | Use Central Contact | Astellas Pharma Global Development |
More Information
| Responsible Party: | Astellas Pharma Global Development ( Sr. Manager Clinical Trials Registry ) |
| Study ID Numbers: | 6517-CL-0020 |
| Study First Received: | October 1, 2009 |
| Last Updated: | November 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00989001 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Mexico: Federal Commission for Sanitary Risks Protection; Peru: Instituto Nacional de Salud; Chile: Instituto de Salud Publica de Chile; South Africa: Medicines Control Council; Israel: Ministry of Health |
|
Atrial Fibrillation RSD1235 Vernakalant conversion |
|
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |