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

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 Intervention Phase
Atrial Fibrillation
Drug: Azimilide Dihydrochloride
Drug: Placebo
Drug: Sotalol
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • To prolong the time to first symptomatic or asymptomatic AFIB, etc event [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Enrollment: 658
Study Start Date: February 2001
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
placebo tablets
Drug: Placebo
tablets, twice daily for 6 months
2: Active Comparator
Sotalol
Drug: Sotalol
160 mg sot twice daily for 6 months
3: Experimental
azimilide
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035451

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

No publications provided

Responsible Party: Procter & Gamble Pharmaceuticals ( Paloma Cuenca, MD )
Study ID Numbers: 1999105
Study First Received: May 3, 2002
Last Updated: July 17, 2009
ClinicalTrials.gov Identifier: NCT00035451     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Calcium Channel Blockers
Cardiovascular Agents
Azimilide
Sotalol
Calcium, Dietary
Adrenergic beta-Antagonists
Adrenergic Antagonists
Atrial Fibrillation
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Arrhythmias, Cardiac

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

ClinicalTrials.gov processed this record on September 11, 2009