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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiome Pharma; Correvio International Sarl
• Collaborator: Astellas Pharma US, Inc.

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.