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| Sponsor: | Cardiome Pharma |
|---|---|
| Information provided by: | Cardiome Pharma |
| ClinicalTrials.gov Identifier: | NCT00526136 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
|---|---|
|
Placebo Comparator: 1
Placebo (b.i.d.)
|
Drug: Placebo |
|
Experimental: 2
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.)
Other Name: RSD1235-SR
|
|
Experimental: 3
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.)
Other Name: RSD1235-SR
|
|
Experimental: 4
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.)
Other Name: RSD1235-SR
|
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
Show 152 Study Locations| Study Director: | Gregory Beatch, PhD | Cardiome Pharma |
More Information
| Responsible Party: | Gregory Beatch, Ph.D., Vice President, Scientific Affairs, Cardiome Pharma Corp. |
| ClinicalTrials.gov Identifier: | NCT00526136 History of Changes |
| Other Study ID Numbers: | 1235-SR-202-AF |
| Study First Received: | September 5, 2007 |
| Last Updated: | December 17, 2008 |
| 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 |
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Atrial Fibrillation |
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Atrial Fibrillation Recurrence Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Disease Attributes |