Clinical trial NCT00468767: Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Official title: A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
RSD1235
Atrial fibrillation of 3 hours to 7 days duration.
Atrial fibrillation of 3 hours to 45 days duration.
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2007-05-03
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.
timeFrame: 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:
measure: To assess the safety of RSD1235 in this patient population.
timeFrame: 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.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Orlando
country: United States
facility: Florida Heart Institute
state: Florida
city: Tampa
country: United States
facility: James Haley VA Hospital
state: Florida
city: Boston
country: United States
facility: Cardiac Arrhythmia Service, Massachusetts General Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Thoracic and Cardiovascular Institute
state: Michigan
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Wynnewood
country: United States
facility: Main Line Health Heart Center
state: Pennsylvania
city: Richmond
country: United States
facility: Medical College of Virginia
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Calgary
country: Canada
facility: Heart Health Institute, Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Victoria
country: Canada
facility: Cardiac Arrhythmia Trials
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences, Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospitals (Civic & General)
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Emergency Medicine Research Program
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: CHUM-Hotel-Dieu de Montreal
state: Quebec
city: Ste Foy
country: Canada
facility: Institute de Cardiologie de Quebec, Hopital Laval
state: Quebec
city: Terrebonne
country: Canada
facility: Centre Hospitalier LeGardeur
state: Quebec
city: Aalborg
country: Denmark
facility: Aalborg University
city: Arhus
country: Denmark
facility: Århus Amtssygehus, Med. kardiologisk
city: Esbjerg
country: Denmark
facility: Centralsygehuset Esbjerg Varde
city: Fredericia
country: Denmark
facility: Fredericia Sygehus
city: Frederikssund
country: Denmark
facility: Frederikssund Sygehus
city: Glostrup
country: Denmark
facility: Glostrup Amtssygehus
city: Haderslev
country: Denmark
facility: Haderslev Sygehus, Kardiologisk Laboratorium
city: Hellerup
country: Denmark
facility: Gentofte Amtssygehus
city: Helsingor
country: Denmark
facility: Helsingor Sygehus, Kardiovaskulært
city: Herlev
country: Denmark
facility: Herlev Amtssygehus, Kardiologisk
city: Hillerod
country: Denmark
facility: Hillerod Sygehus, Medicinsk
city: Hjorring
country: Denmark
facility: Sygehus Vendsyssel Hjorring
city: Holstebro
country: Denmark
facility: Holstebro centralsygehus
city: Horsens
country: Denmark
facility: Horsens Sygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Kardiologisk
city: Kobenhavn
country: Denmark
facility: Amager Hospital, Med. Center
city: Kobenhavn
country: Denmark
facility: H:S Bispebjerg Hospital
city: Koge
country: Denmark
facility: Roskilde Amts Sygehus Køge
city: Kolding
country: Denmark
facility: Kolding Sygehus, Kardiologisk ambulatorium
city: Svendborg
country: Denmark
facility: Sygehus Fyn Svendborg
city: Malmo
country: Sweden
facility: Universitetssjukhuset MAS
city: Molndal
country: Sweden
facility: Universitetssjukhuset, Molndal
city: Orebro
country: Sweden
facility: Universityetssjukhuset, Orebro
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset, Uppsala
city: Vasteras
country: Sweden
facility: Centrallasarettet, Vasteras
Study officials:
affiliation: Advanz Pharma
name: Sheila Grant, MBA
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.