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Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
This study has been completed.
Study NCT00035451   Information provided by Procter and Gamble
First Received: May 3, 2002   Last Updated: July 17, 2009   History of Changes

May 3, 2002
July 17, 2009
February 2001
June 2003   (final data collection date for primary outcome measure)
To prolong the time to first symptomatic or asymptomatic AFIB, etc event [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00035451 on ClinicalTrials.gov Archive Site
 
 
 
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Atrial Fibrillation
  • Drug: Azimilide Dihydrochloride
  • Drug: Placebo
  • Drug: Sotalol
  • Placebo Comparator: placebo tablets
  • Active Comparator: Sotalol
  • Experimental: azimilide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
658
June 2003
June 2003   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain
 
NCT00035451
Paloma Cuenca, MD, Procter & Gamble Pharmaceuticals
1999105
Procter and Gamble
 
Study Director: Paloma Cuenca, MD Procter and Gamble
Procter and Gamble
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP