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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00035451
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : October 3, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Azimilide Dihydrochloride Drug: Placebo Drug: Sotalol Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Study Start Date : February 2001
Primary Completion Date : June 2003
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
placebo tablets
Drug: Placebo
tablets, twice daily for 6 months
Active Comparator: 2
Sotalol
Drug: Sotalol
160 mg sot twice daily for 6 months
Experimental: 3
azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months


Outcome Measures

Primary Outcome Measures :
  1. To prolong the time to first symptomatic or asymptomatic AFIB, etc event [ Time Frame: 6 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00035451


  Show 129 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Paloma Cuenca, MD Procter and Gamble
More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00035451     History of Changes
Other Study ID Numbers: 1999105
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Sotalol
Azimilide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators