A Phase II/III Tolerance and Efficacy Study of RSD1235 in Patients With Atrial Flutter

Completed · Phase 2/Phase 3

Conditions studied: Atrial Flutter

In brief

This study will attempt to demonstrate the effectiveness of RSD1235 in the conversion of atrial flutter (AFL) to sinus rhythm.

Key facts

Study ID

NCT00476112

Run by

Advanz Pharma

People needed

60

Starts

2003-08-01

Expected to finish

2004-09-01

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 dysrhythmic 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 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.

Where it is running

• Regional Cardiology Associates — Sacramento, California, United States
• Thoracic and Cardiovascular Institute — Lansing, Michigan, 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
• Hamilton Health Sciences, Hamilton General Hospital — Hamilton, Ontario, Canada
• Ottawa Hospitals (Civic & General) — Ottawa, 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
• Aalborg University — Aalborg, Denmark
• H:S Bispebjerg Hospital — Copenhagen, Denmark
• Centralsygehuset Esbjerg Varde — Esbjerg, Denmark
• Glostrup Amtssygehus — Glostrup Municipality, Denmark
• Gentofte Amtssygehus — Hellerup, Denmark
• Herlev Amtssygehus, Kardiologisk — Herlev, Denmark
• Sygehus Vendsyssel Hjorring — Hjørring, Denmark
• Holstebro centralsygehus — Holstebro, Denmark
• Hvidovre Hospital, Kardiologisk — Hvidovre, Denmark
• Universitetssjukhuset MAS — Malmö, Sweden
• Centrallasarettet, Vasteras — Västerås, Sweden

Full record on ClinicalTrials.gov

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