Clinical trial NCT00476112: A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Official title: A Phase II/III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Atrial Flutter
Keywords: Atrial flutter
RSD1235
Lead sponsor: Advanz Pharma
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2007-05-21
Enrollment: 60
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 will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.

Detailed description: There are approximately 2 million reported prevalent cases of atrial fibrillation and atrial flutter (AFL) in the United States (Heart Disease \& Stroke Statistics - 2003 Update, AHA). These arrhythmias may be occasional or sustained. AF/AFL is usually associated with age, and general physical condition, rather than with a specific cardiac event, as is often the case with ventricular arrhythmia. While not directly fatal, these arrhythmias cause discomfort and can lead to stroke or congestive heart failure.

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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* 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:

* Have a QRS \> 0.14 s unless patient has pacemaker or uncorrected QT \> 0.440 seconds as measured on a 12-lead ECG.
* 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.

Primary outcomes:
measure: To demonstrate the effectiveness of RSD1235 in the conversion of AFL to sinus rhythm. Treatment will be considered successful if there is treatment-induced conversion of AFL to sinus rhythm for a minimum of 1 minute duration by Hour 1.5.
timeFrame: The proportion of patients with atrial flutter who have treatment-induced conversion of atrial flutter 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 and to assess the efficacy of RSD1235 in lowering the ventricular response rate in patients with AFL.
timeFrame: Treatment-induced reduction of the ventricular response rate within 50 minutes of first exposure to treatment for patient with atrial flutter.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Lansing
country: United States
facility: Thoracic and Cardiovascular Institute
state: Michigan
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: Hamilton
country: Canada
facility: Hamilton Health Sciences, Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospitals (Civic & General)
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: Aalborg
country: Denmark
facility: Aalborg University
city: Esbjerg
country: Denmark
facility: Centralsygehuset Esbjerg Varde
city: Glostrup
country: Denmark
facility: Glostrup Amtssygehus
city: Hellerup
country: Denmark
facility: Gentofte Amtssygehus
city: Herlev
country: Denmark
facility: Herlev Amtssygehus, Kardiologisk
city: Hjorring
country: Denmark
facility: Sygehus Vendsyssel Hjorring
city: Holstebro
country: Denmark
facility: Holstebro centralsygehus
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Kardiologisk
city: Kobenhavn
country: Denmark
facility: H:S Bispebjerg Hospital
city: Malmo
country: Sweden
facility: Universitetssjukhuset MAS
city: Vasteras
country: Sweden
facility: Centrallasarettet, Vasteras
Study officials:
affiliation: Advanz Pharma
name: Sheila Grant, MBA
role: STUDY_DIRECTOR
References:
citation: 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.