Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients

Atrial fibrillation (an 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. 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 prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. 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. The follow-up phase of the study is designed 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: Azimilide Dihydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N4N1
      • University of Calgary
    • Calgary, Alberta, Canada, T2E7C5
      • Heart Health Institute
    • Calgary, Alberta, Canada, T2E7C5
      • Heart Health Research Center
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Cardiology Research St. Paul's Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton Health Science Corp.
    • London, Ontario, Canada, N6A5A5
      • Cardiac Investigation Unit
    • Niagara Falls, Ontario, Canada, L2E7H1
      • Niagara Health System Greater Niagara General Hospital
    • Ottawa, Ontario, Canada, K1Y4W7
      • University of Ottawa Heart Institute
    • Sudbury, Ontario, Canada, P3E6B4
      • Neureka Research Corporation
    • Toronto, Ontario, Canada, M5B1W6
      • St. Michael's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2L4M1
      • Recharche Cardiologie
    • Montreal, Quebec, Canada, H2WIT8
      • CHUM Hôtel Dieu
    • Montreal, Quebec, Canada, H4J1C5
      • Hospital Sacre-Soeur de Montreal
    • Sainte-Foy, Quebec, Canada, G1V4G5
      • Quebec Heart Institute
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Cardiovascular Assoc. PC
    • Mobile, Alabama, United States, 36608
      • The Heart Group, PC
  • Arizona
    • Tucson, Arizona, United States, 85742
      • University Medical Center
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas Medical Center
  • California
    • Burlingame, California, United States, 94010
      • Cardiovascular Associates of Penisula
    • Carmichael, California, United States, 95608
      • Capitol Interventional Cardiology
    • Fresno, California, United States, 93720
      • Valley Research
    • Fresno, California, United States, 93703
      • VA Central California Health Care System
    • Grass Valley, California, United States, 95945
      • Grass Valley Cardiology
    • La Jolla, California, United States, 92037
      • San Diego Cardiovascular Associates
    • 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, 95355
      • Sutter Gould Medical Foundation
    • Redondo Beach, California, United States, 90277
      • ARI Clinical Trials
    • Sacramento, California, United States, 95825
      • Sacramento Heart And Vascular Medical Associates
    • Sacramento, California, United States, 95819
      • Regional Cardiology Assoc.
    • San Diego, California, United States, 92120
      • Cardiology Associates
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Aurora Denver Cardiology
    • 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.
    • Ft. Myers, Florida, United States, 33919
      • SW Florida Heart Group/Health Park Medical Center
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Lakeland, Florida, United States, 33805
      • Watson Clinic, LLP
    • Merritt Island, Florida, United States, 32952
      • Khalid Hassan Sheikh 80 Fontenberry Road
    • Orlando, Florida, United States, 32803
      • Florida Cardiology
    • Ormond Beach, Florida, United States, 32174
      • Cardiology Research Assiocates
  • Georgia
    • Decatur, Georgia, United States, 30033
      • VA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Mount Sinal Hospital Medical Center
    • Elgin, Illinois, United States, 60120
      • Elgin Cardiology Associates
    • Normal, Illinois, United States, 61761-3587
      • Illinois Heart & Lung Research Center, Sc
    • Park Ridge, Illinois, United States, 60068
      • The Center for Advanced Cardiology
  • Indiana
    • Ft. Wayne, Indiana, United States, 46804
      • Heart Center Medical Group
    • Indianapolis, Indiana, United States, 46260-1919
      • The Care Group
  • Kansas
    • Wichita, Kansas, United States, 67203
      • Professional Research Network of Kansas
  • 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, MD 501 S Ryan Street
    • Morgan City, Louisiana, United States, 70380
      • Cardiovascular of the South
    • New Iberia, Louisiana, United States, 70560
      • Cardiovascular Institute of the South
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
    • Slidell, Louisiana, United States, 70458
      • Medical Research Institute
    • Thibodaux, Louisiana, United States, 70301
      • Cardiovascular Institute of the South
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusett
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Thoracic & Cardiovascular Healthcare Foundation
    • Petoskey, Michigan, United States, 49770
      • Nisus Research
    • Trenton, Michigan, United States, 48183
      • Riverside Osteopathic Hospital
  • Minnesota
    • :Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Therapeutic Section
    • Duluth, Minnesota, United States, 55802
      • Regional Heart Center
    • Hibbing, Minnesota, United States, 55746
      • Fairview Range Regional Health Services
  • Montana
    • Missoula, Montana, United States, 59802
      • St. Patrick Hosp/Western Mt. Clinic Cardiology
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Internal Medical Associates
  • New Hampshire
    • Rochester, New Hampshire, United States, 03867
      • William Olney, MD 21 Whitehall Rd, Suite 200
  • New York
    • Williamsville, New York, United States, 14221
      • Cardiology & Int. Medicine
  • 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, 44106-5038
      • University Hospitals of Cleveland
    • Columbus, Ohio, United States, 43214
      • MidWest Cardiology Research Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Foundation for Cardiovascular Research
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Hillsboro Cardiology
    • Portland, Oregon, United States, 97201
      • Oregon Health Sciences University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18106-0880
      • Heart Care Group PC
    • Beaver, Pennsylvania, United States, 15009
      • Tri-State Medical Group Cardiology
    • Hershey, Pennsylvania, United States, 17033-0850
      • 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.
  • 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, 75390-9047
      • 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
    • Chesapeake, Virginia, United States, 23321
      • MedSource, Inc
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center
  • Washington
    • Seattle, Washington, United States, 95165
      • Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
  • Wisconsin
    • Beloit, Wisconsin, United States, 53511
      • Beloit Clinic, SC
    • Janesville, Wisconsin, United States, 53547-0551
      • Dean/Riverview Clinic
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Madison
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic

Participation Criteria

Eligibility Criteria

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

Description

Inclusion criteria:

• History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
• History of congestive heart failure and/or ischemic heart disease
• Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
• At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
• Sinus rhythm immediately prior to dosing

Exclusion criteria:

• Previously unsuccessful cardioversions within 60 days of screening period
• 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
• Previously in an azimilide study

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	Drug: Placebo; placebo tablets, twice a day for 6 months
Experimental: 2; 125 mg azimilide tablets	Drug: Azimilide Dihydrochloride; 125 mg azimilide tablets, twice a day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To prolong the tachycardia-free period in patients	6 months

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Martin Phillips, MD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: December 1, 2000
• Primary Completion (Actual): January 1, 2004
• Study Completion (Actual): January 1, 2004

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: 2000037