Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Official Title: “Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.”

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

Intervention(s) in this Clinical Trial

• Drug: Azimilide Dihydrochloride
  • 125 mg azimilide tablets, twice a day for 6 months
• Drug: Placebo
  • tablets, twice daily for 6 months
• Drug: Sotalol
  • 160 mg sot twice daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • placebo tablets
• Active Comparator: 2
  • Sotalol
• Experimental: 3
  • azimilide

Primary Measures

• To prolong the time to first symptomatic or asymptomatic AFIB, etc event
  • Time Frame: 6 month
    Safety Issue?: No

Inclusion criteria:

• Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening
• Require the procedure of cardioversion (electric shock to correct abnormal rhythm)
• In the investigator's opinion, is likely to maintain sinus rhythm after cardioversion.
• Be anticoagulated according to the recommendations of the Study Group on Atrial
• Fibrillation of the European Society of Cardiology guidelines.

Exclusion criteria:

• Previously unsuccessful electrical cardioversions
• Failed to respond to any Class III antiarrhythmic drugs
• Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Forest Laboratories Industry

Overall Clinical Trial Officials and Contacts

Paloma Cuenca, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00035451

Study ID Number: 1999105

ClinicalTrials.gov Identifier: NCT00035451

Health Authority: United States: Food and Drug Administration