Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
This study has been completed.
First Received: May 3, 2002   Last Updated: July 17, 2009   History of Changes
Sponsor: Procter and Gamble
Information provided by: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00035464
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Azimilide Dihydrochloride
Drug: Placebo
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 of Azimilide in the Prophylactic Treatment of Patients

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • To prolong the tachycardia-free period in patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 431
Study Start Date: December 2000
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator
Placebo tablets
Drug: Placebo
placebo tablets, twice a day for 6 months
2: Experimental
125 mg azimilide tablets
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035464

  Hide Study Locations
Locations
United States, Alabama
Cardiovascular Assoc. PC
Birmingham, Alabama, United States, 35213
The Heart Group, PC
Mobile, Alabama, United States, 36608
United States, Arizona
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
Tucson, Arizona, United States, 85723
University Medical Center
Tucson, Arizona, United States, 85742
United States, Arkansas
University of Arkansas Medical Center
Little Rock, Arkansas, United States, 72205
United States, California
Capitol Interventional Cardiology
Carmichael, California, United States, 95608
Good Samaritan Hospital
Los Angeles, California, United States, 90017
VA Central California Health Care System
Fresno, California, United States, 93703
San Diego Cardiovascular Associates
La Jolla, California, United States, 92037
Sacramento Heart and Vascular Medical Associates
Sacramento, California, United States, 95825
Valley Research
Fresno, California, United States, 93720
Grass Valley Cardiology
Grass Valley, California, United States, 95945
LAC+USC Medical Center
Los Angeles, California, United States, 90033
ARI Clinical Trials
Redondo Beach, California, United States, 90277
Merced Heart Associates
Merced, California, United States, 95340
Cardiovascular Associates of Penisula
Burlingame, California, United States, 94010
Cardiology Associates
San Diego, California, United States, 92120
Sutter Gould Medical Foundation
Modesto, California, United States, 95355
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, United States, 90073
Regional Cardiology Assoc.
Sacramento, California, United States, 95819
United States, Colorado
Aurora Denver Cardiology
Aurora, Colorado, United States, 80012
Western Cardiology Assoc.
Denver, Colorado, United States, 80218
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, District of Columbia
The George Washington University MFA
Washington, District of Columbia, United States, 20037
United States, Florida
Watson Clinic, LLP
Lakeland, Florida, United States, 33805
SW Florida Heart Group/Health Park Medical Center
Ft. Myers, Florida, United States, 33919
Cardiology Research Assiocates
Ormond Beach, Florida, United States, 32174
Cardiology Consultants
Daytona Beach, Florida, United States, 32114
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Khalid Hassan Sheikh 80 Fontenberry Road
Merritt Island, Florida, United States, 32952
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, United States, 33316
Florida Cardiology
Orlando, Florida, United States, 32803
United States, Georgia
VA Medical Center
Decatur, Georgia, United States, 30033
United States, Illinois
The Center for Advanced Cardiology
Park Ridge, Illinois, United States, 60068
Mount Sinal Hospital Medical Center
Chicago, Illinois, United States, 60608
Illinois Heart & Lung Research Center, SC
Normal, Illinois, United States, 61761-3587
Elgin Cardiology Associates
Elgin, Illinois, United States, 60120
United States, Indiana
Heart Center Medical Group
Ft. Wayne, Indiana, United States, 46804
The Care Group
Indianapolis, Indiana, United States, 46260-1919
United States, Kansas
Professional Research Network of Kansas
Wichita, Kansas, United States, 67203
United States, Kentucky
Louisville Cardiology Medical Group, P.S.C
Louisville, Kentucky, United States, 40207
University of Louisville-Cardiology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Medical Research Institute
Slidell, Louisiana, United States, 70458
Cardiovascular Institute of the South
Thibodaux, Louisiana, United States, 70301
Cardiovascular Institute of the South
New Iberia, Louisiana, United States, 70560
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Cardiovascular of the South
Morgan City, Louisiana, United States, 70380
Richard Gilmore, MD 501 S Ryan Street
Lake Charles, Louisiana, United States, 70601
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
University of Massachusett
Worcester, Massachusetts, United States, 01655
United States, Michigan
Nisus Research
Petoskey, Michigan, United States, 49770
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States, 48910
Riverside Osteopathic Hospital
Trenton, Michigan, United States, 48183
United States, Minnesota
Regional Heart Center
Duluth, Minnesota, United States
VA Medical Center Therapeutic Section
:Minneapolis, Minnesota, United States, 55417
Fairview Range Regional Health Services
Hibbing, Minnesota, United States, 55746
United States, Montana
St. Patrick Hosp/Western Mt. Clinic Cardiology
Missoula, Montana, United States, 59802
United States, Nebraska
Internal Medical Associates
Grand Island, Nebraska, United States, 68803
United States, New Hampshire
William Olney, MD 21 Whitehall Rd, Suite 200
Rochester, New Hampshire, United States, 03867
United States, New York
Cardiology & Int. Medicine
Williamsville, New York, United States, 14221
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
United States, North Dakota
Altru Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
MidWest Cardiology Research Foundation
Columbus, Ohio, United States, 43214
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5038
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201
Hillsboro Cardiology
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, United States, 15224
The Pavillion
Jenkintown, Pennsylvania, United States, 19046
Heart Care Group PC
Allentown, Pennsylvania, United States, 18106-0880
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, United States, 15009
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, South Carolina
Charleston Cardiology
Charleston, South Carolina, United States, 29403
United States, Tennessee
Stern Cardiovascular Center Research Department
Memphis, Tennessee, United States, 38120
United States, Texas
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, United States, 78217
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9047
Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
MedSource, Inc
Chesapeake, Virginia, United States, 23321
Riverside Regional Medical Center
Newport News, Virginia, United States, 23601
United States, Washington
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
Seattle, Washington, United States, 95165
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Beloit Clinic, SC
Beloit, Wisconsin, United States, 53511
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Dean/Riverview Clinic
Janesville, Wisconsin, United States, 53547-0551
Canada, Alberta
Heart Health Research Center
Calgary, Alberta, Canada, T2E7C5
Heart Health Institute
Calgary, Alberta, Canada, T2E7C5
University of Calgary
Calgary, Alberta, Canada, T2N4N1
Canada, British Columbia
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Canada, Ontario
Niagara Health System Greater Niagara General Hospital
Niagara Falls, Ontario, Canada, L2E7H1
Hamilton Health Science Corp.
Hamilton, Ontario, Canada, L8L2X2
Neureka Research Corporation
Sudbury, Ontario, Canada, P3E6B4
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y4W7
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W6
Cardiac Investigation Unit
London, Ontario, Canada, N6A5A5
Canada, Quebec
Chum Hotel Dieu
Montreal, Quebec, Canada, H2WIT8
Recharche Cardiologie
Montreal, Quebec, Canada, H2L4M1
Hospital Sacre-Soeur de Montreal
Montreal, Quebec, Canada, H4J1C5
Quebec Heart Institute
Sainte-Foy, Quebec, Canada, G1V4G5
Montreal Heart Institute
Montreal, Quebec, Canada, H1T1C8
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: Martin Phillips, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Procter & Gamble Pharmaceuticals ( Martin Phillips, MD )
Study ID Numbers: 2000037
Study First Received: May 3, 2002
Last Updated: July 17, 2009
ClinicalTrials.gov Identifier: NCT00035464     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Azimilide
Membrane Transport Modulators
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009