Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (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. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).

This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce 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 study. This follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Placebo; Drug: Azimilide Dihydrochloride

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • University of Calgary
    • Calgary, Alberta, Canada, T2V 1P9
      • Rockyview General Hospital CV Lab Research
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Cardiology Research St. Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E0Z3
      • Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton Health Sciences Crop
    • London, Ontario, Canada, N6A 5A5
      • Cardiac Investigation Unit
    • Ottawa, Ontario, Canada, K1Y 4W7
      • University of Ottawa Heart Institute
    • Sudbury, Ontario, Canada, P3E6B4
      • Neureka Research Corporation
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2L4M1
      • Recherche Cardiologie
    • Montreal, Quebec, Canada, H4J1C5
      • Hospital Sacre-Coeur de Montreal
    • Sainte-Foy, Quebec, Canada, G1V4G5
      • Quebec Heart Institute
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • The Heart Group, PC
  • Arizona
    • Tucson, Arizona, United States, 85742
      • University Medical Center
  • California
    • Burlingame, California, United States, 94010
      • Cardiovascular Associates of Penisula
    • Encinitas, California, United States, 92024
      • San Diego Cardiovascular Research Associates
    • La Mesa, California, United States, 91942
      • La Mesa Cardiac Center, A Medical Group
    • Los Angeles, California, United States, 90033
      • LAC + USC Medical Center
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Los Angeles, California, United States, 90073
      • Cardiology Section, West Los Angeles VA Hospital
    • Merced, California, United States, 95340
      • Merced Heart Associates
    • Modesto, California, United States, 95335
      • Sutter Gould Medical Foundation
    • Redondo Beach, California, United States, 90277
      • ARI Clinical Trials
    • Riverside, California, United States, 92501
      • Inland Clinical Research
    • Sacramento, California, United States, 95819
      • Regional Cardiology Assoc.
    • San Diego, California, United States, 92120
      • Cardiology Associates
  • Colorado
    • Denver, Colorado, United States, 80218
      • Western Cardiology Assoc.
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University MFA
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Cardiology Consultants
    • Fort Lauderdale, Florida, United States, 33316
      • C/O Research Office Attn: Cardiovascular Research Dept.
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Medical
    • Merritt Island, Florida, United States, 32952
      • Khalid Hasan Sheikh 80 Fortenberry Road
    • Orlando, Florida, United States, 32803
      • Florida Cardiology
    • Ormond Beach, Florida, United States, 32174
      • Cardiology Reasearch Assiocates
  • Georgia
    • Decatur, Georgia, United States, 30033
      • VA Medical Center
  • Illinois
    • Elgin, Illinois, United States, 60120
      • Elgin Cardiology Associates
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Indiana
    • Ft. Wayne, Indiana, United States, 46804
      • Heart Center Medical Group
    • Indianapolis, Indiana, United States, 46260
      • The Care Group
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville-Cardiology
    • Louisville, Kentucky, United States, 40207
      • Louisville Cardiology Medical Group, P.S.C.
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
    • Lake Charles, Louisiana, United States, 70601
      • Richard Gilmore 501 S. Ryan Street
    • Morgan City, Louisiana, United States, 70380
      • Cardiovascular Instiute of the South
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Maine
    • Auburn, Maine, United States, 04201
      • Androscoggin Cardiology Associates Research
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusett
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Thoracic & Cardiovascular Healthcare Foundation
    • Trenton, Michigan, United States, 48183
      • Riverside Osteopathic Hospital
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Regional Heart Center
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Therapeutic Section
    • St. Paul, Minnesota, United States, 55102
      • St. Paul Heart Clinic
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Medical Center
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Clinical Trial Ctr.
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Of Cleveland
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Hillsboro Cardiology
    • Portland, Oregon, United States, 97201
      • Oregon Health Sciences University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18106
      • Heart Care Group PC
    • Beaver, Pennsylvania, United States, 15009
      • Tri-State Medical Group Cardiology
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
    • Jenkintown, Pennsylvania, United States, 19046
      • The Pavillion
    • Philadelphia, Pennsylvania, United States, 19104
      • UPHS/Presbyterian Medical Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • Cardiovascular and Critical Care Associates, P.C.
    • Wynnewood, Pennsylvania, United States, 19096
      • Cardiology Foundation of Lankenau
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Cardiology
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Stern Cardiovascular Center Research Department
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • Methodist Hospital
    • San Antonio, Texas, United States, 78217
      • Heart and Vascular Inst. of Texas, PA
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center
  • Washington
    • Seattle, Washington, United States, 98166
      • Daniel Gottlieb 16259 Sylvester Road SW Suite 401
    • Tacoma, Washington, United States, 98405
      • FHS Research
  • Wisconsin
    • Beloit, Wisconsin, United States, 53511
      • Beloit Clinic, SC
    • Elkhorn, Wisconsin, United States, 53121
      • Wisconsin Center for Clinical Research
    • Janesville, Wisconsin, United States, 53547
      • Dean/Riverview Clinic
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Madison
    • Milwaukee, Wisconsin, United States, 53251
      • Wisconsin Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 heart rhythm)
• In the investigator's opinion, be 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; placebo tablets in hospital and placebo tablets outpatient	Drug: Placebo; placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Experimental: 2; Azimilide tablets in hospital and azimilide tablets outpatient	Drug: Azimilide Dihydrochloride; 125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc	six months

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Preston M Dunnmon, MD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: May 3, 2002
• First Submitted That Met QC Criteria: May 3, 2002
• First Posted (Estimate): May 6, 2002

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Azimilide
• Other Study ID Numbers: 2000038