Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
NCT ID: NCT00468767
Last Updated: 2008-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2003-08-31
2004-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Atrial fibrillation (AF) duration of 3 hours to 7 days.
Vernakalant Injection 20 mg/mL
2
AF duration of \>7 days to \<45 days
Vernakalant Injection 20 mg/mL
Interventions
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Vernakalant Injection 20 mg/mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an atrial arrhythmia with symptoms that has been sustained for greater than 3 hours and up to 45 days.
* Have adequate anticoagulant therapy.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Advanz Pharma
INDUSTRY
Responsible Party
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Cardiome Pharma Corp.
Principal Investigators
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Sheila Grant, MBA
Role: STUDY_DIRECTOR
Advanz Pharma
Locations
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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
Main Line Health Heart Center
Wynnewood, Pennsylvania, United States
Medical College of Virginia
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Heart Health Institute, Rockyview General Hospital
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, Canada
Institute de Cardiologie de Quebec, Hopital Laval
Ste Foy, Quebec, Canada
Centre Hospitalier LeGardeur
Terrebonne, Quebec, Canada
Aalborg University
Aalborg, , Denmark
Århus Amtssygehus, Med. kardiologisk
Aarhus, , Denmark
Amager Hospital, Med. Center
Copenhagen, , Denmark
H:S Bispebjerg Hospital
Copenhagen, , Denmark
Helsingor Sygehus, Kardiovaskulært
Elsinore, , Denmark
Centralsygehuset Esbjerg Varde
Esbjerg, , Denmark
Fredericia Sygehus
Fredericia, , Denmark
Frederikssund Sygehus
Frederikssund, , Denmark
Glostrup Amtssygehus
Glostrup Municipality, , Denmark
Haderslev Sygehus, Kardiologisk Laboratorium
Haderslev, , Denmark
Gentofte Amtssygehus
Hellerup, , Denmark
Herlev Amtssygehus, Kardiologisk
Herlev, , Denmark
Hillerod Sygehus, Medicinsk
Hillerød, , Denmark
Sygehus Vendsyssel Hjorring
Hjørring, , Denmark
Holstebro centralsygehus
Holstebro, , Denmark
Horsens Sygehus
Horsens, , Denmark
Hvidovre Hospital, Kardiologisk
Hvidovre, , Denmark
Kolding Sygehus, Kardiologisk ambulatorium
Kolding, , Denmark
Roskilde Amts Sygehus Køge
Køge, , Denmark
Sygehus Fyn Svendborg
Svendborg, , Denmark
Universitetssjukhuset MAS
Malmo, , Sweden
Universitetssjukhuset, Molndal
Mölndal, , Sweden
Universityetssjukhuset, Orebro
Örebro, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Akademiska Sjukhuset, Uppsala
Uppsala, , Sweden
Centrallasarettet, Vasteras
Västerås, , Sweden
Countries
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References
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Stiell IG, Dickinson G, Butterfield NN, Clement CM, Perry JJ, Vaillancourt C, Calder LA. Vernakalant hydrochloride: A novel atrial-selective agent for the cardioversion of recent-onset atrial fibrillation in the emergency department. Acad Emerg Med. 2010 Nov;17(11):1175-82. doi: 10.1111/j.1553-2712.2010.00915.x.
Roy D, Pratt CM, Torp-Pedersen C, Wyse DG, Toft E, Juul-Moller S, Nielsen T, Rasmussen SL, Stiell IG, Coutu B, Ip JH, Pritchett EL, Camm AJ; Atrial Arrhythmia Conversion Trial Investigators. Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial. Circulation. 2008 Mar 25;117(12):1518-25. doi: 10.1161/CIRCULATIONAHA.107.723866. Epub 2008 Mar 10.
Other Identifiers
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1235-0703
Identifier Type: -
Identifier Source: org_study_id