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

Completed · Phase 3

Conditions studied: Atrial Fibrillation

In brief

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

Key facts

Study ID

NCT00468767

Run by

Advanz Pharma

People needed

356

Starts

2003-08-01

Expected to finish

2004-11-01

Last updated by the study team

2008-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• University of California — Los Angeles, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Florida Heart Institute — Orlando, Florida, United States
• James Haley VA Hospital — Tampa, Florida, United States
• Cardiac Arrhythmia Service, Massachusetts General Hospital — Boston, Massachusetts, United States
• Thoracic and Cardiovascular Institute — Lansing, Michigan, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Main Line Health Heart Center — Wynnewood, Pennsylvania, 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
• Cardiac Arrhythmia Trials — Victoria, British Columbia, Canada
• Hamilton Health Sciences, Hamilton General Hospital — Hamilton, Ontario, Canada
• Ottawa Hospitals (Civic & General) — Ottawa, Ontario, Canada
• Sunnybrook Health Sciences Centre, Emergency Medicine Research Program — Toronto, 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
• Institute de Cardiologie de Quebec, Hopital Laval — Ste Foy, Quebec, Canada
• Centre Hospitalier LeGardeur — Terrebonne, Quebec, Canada
• Aalborg University — Aalborg, Denmark
• Århus Amtssygehus, Med. kardiologisk — Aarhus, Denmark

Full record on ClinicalTrials.gov

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