A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
NCT ID: NCT00476112
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
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2003-08-31
2004-09-30
Brief Summary
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Detailed Description
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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.
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 flutter duration of 3 hours 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 dysrhythmic symptoms that has been sustained for greater than 3 hours and up to 45 days.
* Have adequate anticoagulant therapy.
Exclusion Criteria
* Be concurrently participating in another drug study or have received an investigational drug within 30 days prior to enrollment, or have previously received RSD1235.
* Have serious diseases/illnesses that could interfere with the conduct or validity of the study or compromise patient safety.
* Have received IV Class I or Class III antiarrhythmic drugs or IV 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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Regional Cardiology Associates
Sacramento, California, United States
Thoracic and Cardiovascular Institute
Lansing, Michigan, 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
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, Canada
Ottawa Hospitals (Civic & General)
Ottawa, 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
Aalborg University
Aalborg, , Denmark
H:S Bispebjerg Hospital
Copenhagen, , Denmark
Centralsygehuset Esbjerg Varde
Esbjerg, , Denmark
Glostrup Amtssygehus
Glostrup Municipality, , Denmark
Gentofte Amtssygehus
Hellerup, , Denmark
Herlev Amtssygehus, Kardiologisk
Herlev, , Denmark
Sygehus Vendsyssel Hjorring
Hjørring, , Denmark
Holstebro centralsygehus
Holstebro, , Denmark
Hvidovre Hospital, Kardiologisk
Hvidovre, , Denmark
Universitetssjukhuset MAS
Malmo, , Sweden
Centrallasarettet, Vasteras
Västerås, , Sweden
Countries
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References
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Camm AJ, Toft E, Torp-Pedersen C, Vijayaraman P, Juul-Moller S, Ip J, Beatch GN, Dickinson G, Wyse DG; Scene 2 Investigators. Efficacy and safety of vernakalant in patients with atrial flutter: a randomized, double-blind, placebo-controlled trial. Europace. 2012 Jun;14(6):804-9. doi: 10.1093/europace/eur416. Epub 2012 Jan 29.
Other Identifiers
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1235-0703B
Identifier Type: -
Identifier Source: org_study_id