Phase III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ACT I  

Official title:

A Phase III Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Centred Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468767
• Other study ID #: 1235-0703
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2007
• Last updated: March 31, 2008
• Start date: August 2003
• Est. completion date: November 2004

Study information

• Verified date: March 2008
• Source: Cardiome Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to demonstrate the effectiveness of RSD1235 in the conversion of atrial fibrillation to sinus rhythm.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Vernakalant Injection 20 mg/mL

Locations

Country	Name	City	State
Canada	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	CHUM-Hotel-Dieu de Montreal	Montreal	Quebec
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	Ottawa Hospitals (Civic & General)	Ottawa	Ontario
Canada	Institute de Cardiologie de Quebec, Hopital Laval	Ste Foy	Quebec
Canada	Centre Hospitalier LeGardeur	Terrebonne	Quebec
Canada	Sunnybrook Health Sciences Centre, Emergency Medicine Research Program	Toronto	Ontario
Canada	Cardiac Arrhythmia Trials	Victoria	British Columbia
Denmark	Aalborg University	Aalborg
Denmark	Århus Amtssygehus, Med. kardiologisk	Arhus
Denmark	Centralsygehuset Esbjerg Varde	Esbjerg
Denmark	Fredericia Sygehus	Fredericia
Denmark	Frederikssund Sygehus	Frederikssund
Denmark	Glostrup Amtssygehus	Glostrup
Denmark	Haderslev Sygehus, Kardiologisk Laboratorium	Haderslev
Denmark	Gentofte Amtssygehus	Hellerup
Denmark	Helsingor Sygehus, Kardiovaskulært	Helsingor
Denmark	Herlev Amtssygehus, Kardiologisk	Herlev
Denmark	Hillerod Sygehus, Medicinsk	Hillerod
Denmark	Sygehus Vendsyssel Hjorring	Hjorring
Denmark	Holstebro centralsygehus	Holstebro
Denmark	Horsens Sygehus	Horsens
Denmark	Hvidovre Hospital, Kardiologisk	Hvidovre
Denmark	Amager Hospital, Med. Center	Kobenhavn
Denmark	H:S Bispebjerg Hospital	Kobenhavn
Denmark	Roskilde Amts Sygehus Køge	Koge
Denmark	Kolding Sygehus, Kardiologisk ambulatorium	Kolding
Denmark	Sygehus Fyn Svendborg	Svendborg
Sweden	Universitetssjukhuset MAS	Malmo
Sweden	Universitetssjukhuset, Molndal	Molndal
Sweden	Universityetssjukhuset, Orebro	Orebro
Sweden	Danderyds sjukhus	Stockholm
Sweden	Akademiska Sjukhuset, Uppsala	Uppsala
Sweden	Centrallasarettet, Vasteras	Vasteras
United States	Cardiac Arrhythmia Service, Massachusetts General Hospital	Boston	Massachusetts
United States	Thoracic and Cardiovascular Institute	Lansing	Michigan
United States	University of California	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Florida Heart Institute	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Medical College of Virginia	Richmond	Virginia
United States	Regional Cardiology Associates	Sacramento	California
United States	James Haley VA Hospital	Tampa	Florida
United States	Main Line Health Heart Center	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Cardiome Pharma	Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Yes