Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
ACT I
A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
1 other identifier
interventional
356
4 countries
49
Brief Summary
This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Aug 2003
Shorter than P25 for phase_3 atrial-fibrillation
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 1, 2007
CompletedFirst Posted
Study publicly available on registry
May 3, 2007
CompletedApril 2, 2008
March 1, 2008
1.3 years
May 1, 2007
March 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
1
EXPERIMENTALAtrial fibrillation (AF) duration of 3 hours to 7 days.
2
EXPERIMENTALAF duration of \>7 days to \<45 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Advanz Pharmalead
- Astellas Pharma US, Inc.collaborator
Study Sites (49)
University of California
Los Angeles, California, 90073, United States
Regional Cardiology Associates
Sacramento, California, 95819, United States
Florida Heart Institute
Orlando, Florida, 32803, United States
James Haley VA Hospital
Tampa, Florida, 33612, United States
Cardiac Arrhythmia Service, Massachusetts General Hospital
Boston, Massachusetts, 02459, United States
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48910, United States
Oregon Health & Science University
Portland, Oregon, 97201, United States
Main Line Health Heart Center
Wynnewood, Pennsylvania, 19096, United States
Medical College of Virginia
Richmond, Virginia, 23219, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Heart Health Institute, Rockyview General Hospital
Calgary, Alberta, T2E 7C5, Canada
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Cardiac Arrhythmia Trials
Victoria, British Columbia, V8R 4R2, Canada
Hamilton Health Sciences, Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Ottawa Hospitals (Civic & General)
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
Toronto, Ontario, M4N 3M5, Canada
Institut de Cardiologie de Montreal
Montreal, Quebec, H1T 1C8, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
CHUM-Hotel-Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
Institute de Cardiologie de Quebec, Hopital Laval
Ste Foy, Quebec, G1V 4G5, Canada
Centre Hospitalier LeGardeur
Terrebonne, Quebec, J6V 2H2, 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
Related Publications (2)
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.
PMID: 21175515DERIVEDRoy 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.
PMID: 18332267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sheila Grant, MBA
Advanz Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 1, 2007
First Posted
May 3, 2007
Study Start
August 1, 2003
Primary Completion
November 1, 2004
Study Completion
November 1, 2004
Last Updated
April 2, 2008
Record last verified: 2008-03