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Sponsored by: |
Cardiome Pharma |
---|---|
Information provided by: | Cardiome Pharma |
ClinicalTrials.gov Identifier: | NCT00526136 |
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and < 6 months).
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Drug: Placebo Drug: Vernakalant (oral) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vernakalant (Oral) Prevention of Atrial Fibrillation Recurrence Post-Conversion Study |
Enrollment: | 735 |
Study Start Date: | March 2007 |
Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo (b.i.d.)
|
Drug: Placebo |
2: Experimental
Vernakalant (oral), 150 mg (b.i.d.)
|
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
|
3: Experimental
Vernakalant (oral), 300 mg (b.i.d.)
|
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
|
4: Experimental
Vernakalant (oral), 500 mg (b.i.d.)
|
Drug: Vernakalant (oral)
Vernakalant (oral), 150 mg (b.i.d.) Vernakalant (oral), 300 mg (b.i.d.) Vernakalant (oral), 500 mg (b.i.d.)
|
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Gregory Beatch, PhD | Cardiome Pharma |
Responsible Party: | Cardiome Pharma Corp. ( Gregory Beatch, Ph.D., Vice President, Scientific Affairs ) |
Study ID Numbers: | 1235-SR-202-AF |
Study First Received: | September 5, 2007 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00526136 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Bulgaria: Bulgarian Drug Agency; Bulgaria: Ministry of Health; Croatia: Ethics Committee; Croatia: Ministry of Health and Social Care; Czech Republic: Ethics Committee; Czech Republic: State Institute for Drug Control; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Estonia: The State Agency of Medicine; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Lithuania: Bioethics Committee; Lithuania: State Medicine Control Agency - Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC); New Zealand: Medsafe; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Romania: Ministry of Public Health; Romania: National Medicines Agency; Russia: Ethics Committee; Russia: FSI Scientific Center of Expertise of Medical Application; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Serbia: Ethics Committee; Singapore: Health Sciences Authority; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Ministry of Health and Consumption; Sweden: Medical Products Agency; Switzerland: Swissmedic; Ukraine: State Pharmacological Center - Ministry of Health |
Atrial Fibrillation |
Heart Diseases Atrial Fibrillation Recurrence Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |