Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
- Registration Number
- NCT00468767
- Lead Sponsor
- Advanz Pharma
- Brief Summary
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
- Detailed Description
There are approximately 2 million reported prevalent cases of atrial fibrillation (AF) and atrial flutter in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.
This Phase III trial is Cardiome's first pivotal study with RSD1235. The study seeks to confirm the findings of the Phase II proof-of-concept through demonstration of RSD1235's abilities to convert AF to sinus rhythm. The patient population will include recent onset AF (AF duration of 3 hours to 7 days) and patients with longer AF duration.
This is a double-blind, placebo-controlled, randomized study in patients with AF; stratification will be based on duration of AF. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
- 18 years of age or older;
- Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
- Have adequate anticoagulant therapy.
- Have a QRS > 0.14 seconds unless patient has pacemaker or uncorrected QT > 0.440 seconds as measured on a 12-lead ECG.
- Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
- Have received intravenous Class I or Class III antiarrhythmic drugs or intravenous amiodarone within 24 hours prior to dosing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Vernakalant Injection 20 mg/mL AF duration of \>7 days to \<45 days 1 Vernakalant Injection 20 mg/mL Atrial fibrillation (AF) duration of 3 hours to 7 days.
- Primary Outcome Measures
Name Time Method To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm. The proportion of patients with atrial fibrillation (AF) of 3 hours to 7 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
- Secondary Outcome Measures
Name Time Method To assess the safety of RSD1235 in this patient population. The proportion of patients with AF of 3 hours to 45 days duration who have treatment-induced conversion of AF to sinus rhythm for a minimum duration of one minute in the first 90 minutes after the first exposure to study treatment.
Trial Locations
- Locations (49)
Fredericia Sygehus
🇩🇰Fredericia, Denmark
Frederikssund Sygehus
🇩🇰Frederikssund, Denmark
Glostrup Amtssygehus
🇩🇰Glostrup, Denmark
Sygehus Vendsyssel Hjorring
🇩🇰Hjorring, Denmark
Helsingor Sygehus, Kardiovaskulært
🇩🇰Helsingor, Denmark
Herlev Amtssygehus, Kardiologisk
🇩🇰Herlev, Denmark
Hillerod Sygehus, Medicinsk
🇩🇰Hillerod, Denmark
Hvidovre Hospital, Kardiologisk
🇩🇰Hvidovre, Denmark
Amager Hospital, Med. Center
🇩🇰Kobenhavn, Denmark
H:S Bispebjerg Hospital
🇩🇰Kobenhavn, Denmark
Roskilde Amts Sygehus Køge
🇩🇰Koge, Denmark
Sygehus Fyn Svendborg
🇩🇰Svendborg, Denmark
Centre Hospitalier LeGardeur
🇨🇦Terrebonne, Quebec, Canada
Haderslev Sygehus, Kardiologisk Laboratorium
🇩🇰Haderslev, Denmark
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
CHUM-Hotel-Dieu de Montreal
🇨🇦Montreal, Quebec, Canada
University of Calgary
🇨🇦Calgary, Alberta, Canada
Aalborg University
🇩🇰Aalborg, Denmark
Hamilton Health Sciences, Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Århus Amtssygehus, Med. kardiologisk
🇩🇰Arhus, Denmark
Gentofte Amtssygehus
🇩🇰Hellerup, Denmark
Horsens Sygehus
🇩🇰Horsens, Denmark
Universitetssjukhuset, Molndal
🇸🇪Molndal, Sweden
Universityetssjukhuset, Orebro
🇸🇪Orebro, Sweden
Akademiska Sjukhuset, Uppsala
🇸🇪Uppsala, Sweden
Centrallasarettet, Vasteras
🇸🇪Vasteras, Sweden
Universitetssjukhuset MAS
🇸🇪Malmo, Sweden
Ottawa Hospitals (Civic & General)
🇨🇦Ottawa, Ontario, Canada
Main Line Health Heart Center
🇺🇸Wynnewood, Pennsylvania, United States
Centralsygehuset Esbjerg Varde
🇩🇰Esbjerg, Denmark
Heart Health Institute, Rockyview General Hospital
🇨🇦Calgary, Alberta, Canada
Institut de Cardiologie de Montreal
🇨🇦Montreal, Quebec, Canada
Institute de Cardiologie de Quebec, Hopital Laval
🇨🇦Ste Foy, Quebec, Canada
Holstebro centralsygehus
🇩🇰Holstebro, Denmark
Kolding Sygehus, Kardiologisk ambulatorium
🇩🇰Kolding, Denmark
Danderyds sjukhus
🇸🇪Stockholm, Sweden
Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
🇨🇦Toronto, Ontario, Canada
University of California
🇺🇸Los Angeles, California, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Florida Heart Institute
🇺🇸Orlando, Florida, United States
James Haley VA Hospital
🇺🇸Tampa, Florida, United States
Cardiac Arrhythmia Service, Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Thoracic and Cardiovascular Institute
🇺🇸Lansing, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical College of Virginia
🇺🇸Richmond, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Cardiac Arrhythmia Trials
🇨🇦Victoria, British Columbia, Canada