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Sponsors and Collaborators: |
Cardiome Pharma Astellas Pharma US, Inc. |
Information provided by: | Cardiome Pharma |
ClinicalTrials.gov Identifier: | NCT00476112 |
This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.
Condition | Intervention | Phase |
Atrial Flutter |
Drug: Vernakalant Injection 20 mg/mL |
Phase II Phase III |
Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
ChemIDplus related topics: | RSD 1235 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter |
Enrollment: | 60 |
Study Start Date: | August 2003 |
Study Completion Date: | September 2004 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Atrial flutter duration of 3 hours to <45 days
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Drug: Vernakalant Injection 20 mg/mL |
There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease & Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase II/III trial is Cardiome's first study with RSD1235 for the treatment of atrial flutter. The study seeks to demonstrate RSD1235's abilities to convert AFL to sinus rhythm. The patient population will have atrial flutter of duration greater than 3 hours and less than or equal to 45 days.
This is a double-blind, placebo-controlled, randomized study in patients with AFL; stratification will be based on duration of AFL. Treatment will be considered successful if there is a treatment-induced conversion of atrial arrhythmia to sinus rhythm for a minimum of 1-minute by Hour 1.5 (Time 0 = start of first infusion). All patients will be evaluated for safety.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
Regional Cardiology Associates | |||||
Sacramento, California, United States, 95819 | |||||
United States, Michigan | |||||
Thoracic and Cardiovascular Institute | |||||
Lansing, Michigan, United States, 48910 | |||||
United States, Virginia | |||||
McGuire VA Medical Center | |||||
Richmond, Virginia, United States, 23249 | |||||
Medical College of Virginia | |||||
Richmond, Virginia, United States, 23219 | |||||
United States, Wisconsin | |||||
Marshfield Clinic | |||||
Marshfield, Wisconsin, United States, 54449 | |||||
Canada, Alberta | |||||
University of Alberta Hospital | |||||
Edmonton, Alberta, Canada, T6G 2B7 | |||||
University of Calgary | |||||
Calgary, Alberta, Canada, T2N 4N1 | |||||
Heart Health Institute, Rockyview General Hospital | |||||
Calgary, Alberta, Canada, T2E 7C5 | |||||
Canada, Ontario | |||||
Hamilton Health Sciences, Hamilton General Hospital | |||||
Hamilton, Ontario, Canada, L8L 2X2 | |||||
Ottawa Hospitals (Civic & General) | |||||
Ottawa, Ontario, Canada, K1Y 4E9 | |||||
Canada, Quebec | |||||
Institut de Cardiologie de Montreal | |||||
Montreal, Quebec, Canada, H1T 1C8 | |||||
Hopital Notre-Dame du CHUM | |||||
Montreal, Quebec, Canada, H2L 4M1 | |||||
CHUM-Hotel-Dieu de Montreal | |||||
Montreal, Quebec, Canada, H2W 1T8 | |||||
Denmark | |||||
H:S Bispebjerg Hospital | |||||
Kobenhavn, Denmark | |||||
Centralsygehuset Esbjerg Varde | |||||
Esbjerg, Denmark | |||||
Gentofte Amtssygehus | |||||
Hellerup, Denmark | |||||
Glostrup Amtssygehus | |||||
Glostrup, Denmark | |||||
Herlev Amtssygehus, Kardiologisk | |||||
Herlev, Denmark | |||||
Sygehus Vendsyssel Hjorring | |||||
Hjorring, Denmark | |||||
Hvidovre Hospital, Kardiologisk | |||||
Hvidovre, Denmark | |||||
Aalborg University | |||||
Aalborg, Denmark | |||||
Holstebro centralsygehus | |||||
Holstebro, Denmark | |||||
Sweden | |||||
Universitetssjukhuset MAS | |||||
Malmo, Sweden | |||||
Centrallasarettet, Vasteras | |||||
Vasteras, Sweden |
Cardiome Pharma |
Astellas Pharma US, Inc. |
Study Director: | Sheila Grant, MBA | Cardiome Pharma |
Responsible Party: | Cardiome Pharma Corp. ( Sheila Grant, VP of Product Development, Vernakalant ) |
Study ID Numbers: | 1235-0703B |
First Received: | May 18, 2007 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00476112 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Denmark: Danish Medicines Agency; Sweden: Medical Products Agency |
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