Atrial Fibrillation Clinical Trial
Official title:
A Pilot Phase II, Randomised, Double-Blind, Placebo-Controlled, Multi-Centred Safety, Tolerability and Preliminary Efficacy Study of RSD1235-SR for the Prevention of Atrial Fibrillation/Atrial Flutter (AF/AFL) Recurrence in Subjects Post-Conversion Form AF
This study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration
| Status | Completed |
| Enrollment | 221 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria (partial list): - Subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration - Subjects must have adequate anticoagulant therapy Exclusion Criteria (partial list): - Subjects may not have Class III or Class IV congestive heart failure - Subjects may not have uncorrected electrolyte imbalance |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Hospital | Calgary | Alberta |
| Canada | Centre Hospitalier de l'Université de Montréal (CHUM) Hôtel Dieu | Montréal | Quebec |
| Denmark | Aalborg Sygehus Syd | Aalborg | |
| Denmark | Aarhus Sygehus Kardiologisk Afd. A | Aarhus | |
| Denmark | Kardiologisk/endokrinologisk afd. E Frederiksberg Hospital | Frederiksberg | |
| Denmark | KAS Gentofte Kardiologisk Afdeling | Hellerup | |
| Denmark | KAS Herlev | Herlev | |
| Denmark | Sygehus Vendsyssel Hjorring | Hjorring | |
| Denmark | Bispebjerg Hospital | Kobenhavn | |
| Denmark | Roskilde Amts Sygehus Koge | Koge | |
| Denmark | Medicinsk Afdeling Kolding Sygehus | Kolding | |
| Netherlands | Reinier de Graaf Gasthuis | Delft | |
| Netherlands | Catharina Ziekenhuis | Eindhoven | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | University Medical Center Groningen (UMCG) | Groningen | |
| Netherlands | Trial sectie Cardiologie | Heerlen | |
| Netherlands | Academisch Ziekenhuis Maastricht | Maastricht | |
| Netherlands | Stichting Sint Antonius Ziekenhuis | Nieuwegein | |
| United States | Penn State Heart & Vascular Institute | Hershey | Pennsylvania |
| United States | The Heart Center, P.C. | Huntsville | Alabama |
| United States | Marshfield Clinic | Marshfield | Wisconsin |
| United States | Cardiovascular Consultants Medical Group, Inc. | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Cardiome Pharma |
United States, Canada, Denmark, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | All subjects who were exposed to the investigational medication were evaluated for safety. | Subjects were assessed for safety within Day 58 of dosing | Yes | |
| Secondary | Recurrence of AF/AFL or withdrawal | Time for recurrence of AF/AFL or withdrawal within Day 28 of dosing | No | |
| Secondary | Improvement in AF symptoms | Time to improvement in AF symptoms within Day 28 of dosing | No |
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