Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
NCT ID: NCT00035464
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
431 participants
INTERVENTIONAL
2000-12-31
2004-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Placebo tablets
Placebo
placebo tablets, twice a day for 6 months
2
125 mg azimilide tablets
Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
Placebo
placebo tablets, twice a day for 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Forest Laboratories
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Procter & Gamble Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin Phillips, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular Assoc. PC
Birmingham, Alabama, United States
The Heart Group, PC
Mobile, Alabama, United States
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
Tucson, Arizona, United States
University Medical Center
Tucson, Arizona, United States
University of Arkansas Medical Center
Little Rock, Arkansas, United States
Cardiovascular Associates of Penisula
Burlingame, California, United States
Capitol Interventional Cardiology
Carmichael, California, United States
VA Central California Health Care System
Fresno, California, United States
Valley Research
Fresno, California, United States
Grass Valley Cardiology
Grass Valley, California, United States
San Diego Cardiovascular Associates
La Jolla, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
Cardiology Section, West Los Angeles VA Hospital
Los Angeles, California, United States
Merced Heart Associates
Merced, California, United States
Sutter Gould Medical Foundation
Modesto, California, United States
ARI Clinical Trials
Redondo Beach, California, United States
Regional Cardiology Assoc.
Sacramento, California, United States
Sacramento Heart and Vascular Medical Associates
Sacramento, California, United States
Cardiology Associates
San Diego, California, United States
Aurora Denver Cardiology
Aurora, Colorado, United States
Western Cardiology Assoc.
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
The George Washington University MFA
Washington D.C., District of Columbia, United States
Cardiology Consultants
Daytona Beach, Florida, United States
C/O Research Office Attn: Cardiovascular Research Dept.
Fort Lauderdale, Florida, United States
SW Florida Heart Group/Health Park Medical Center
Fort Myers, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Watson Clinic, LLP
Lakeland, Florida, United States
Khalid Hassan Sheikh 80 Fontenberry Road
Merritt Island, Florida, United States
Florida Cardiology
Orlando, Florida, United States
Cardiology Research Assiocates
Ormond Beach, Florida, United States
VA Medical Center
Decatur, Georgia, United States
Mount Sinal Hospital Medical Center
Chicago, Illinois, United States
Elgin Cardiology Associates
Elgin, Illinois, United States
Illinois Heart & Lung Research Center, SC
Normal, Illinois, United States
The Center for Advanced Cardiology
Park Ridge, Illinois, United States
Heart Center Medical Group
Fort Wayne, Indiana, United States
The Care Group
Indianapolis, Indiana, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
University of Louisville-Cardiology
Louisville, Kentucky, United States
Louisville Cardiology Medical Group, P.S.C
Louisville, Kentucky, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Richard Gilmore, MD 501 S Ryan Street
Lake Charles, Louisiana, United States
Cardiovascular of the South
Morgan City, Louisiana, United States
Cardiovascular Institute of the South
New Iberia, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
Medical Research Institute
Slidell, Louisiana, United States
Cardiovascular Institute of the South
Thibodaux, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Massachusett
Worcester, Massachusetts, United States
Thoracic & Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Nisus Research
Petoskey, Michigan, United States
Riverside Osteopathic Hospital
Trenton, Michigan, United States
Regional Heart Center
Duluth, Minnesota, United States
Fairview Range Regional Health Services
Hibbing, Minnesota, United States
VA Medical Center Therapeutic Section
Minneapolis, Minnesota, United States
St. Patrick Hosp/Western Mt. Clinic Cardiology
Missoula, Montana, United States
Internal Medical Associates
Grand Island, Nebraska, United States
William Olney, MD 21 Whitehall Rd, Suite 200
Rochester, New Hampshire, United States
Cardiology & Int. Medicine
Williamsville, New York, United States
Duke Medical Center
Durham, North Carolina, United States
Altru Health System Research Center
Grand Forks, North Dakota, United States
Lindner Clinical Trial Ctr.
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
MidWest Cardiology Research Foundation
Columbus, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
Hillsboro Cardiology
Hillsboro, Oregon, United States
Oregon Health Sciences University
Portland, Oregon, United States
Heart Care Group PC
Allentown, Pennsylvania, United States
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
The Pavillion
Jenkintown, Pennsylvania, United States
UPHS/Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Cardiovascular and Critical Care Associates, P.C.
Pittsburgh, Pennsylvania, United States
Charleston Cardiology
Charleston, South Carolina, United States
Stern Cardiovascular Center Research Department
Memphis, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
Heart and Vascular Inst. of Texas, PA
San Antonio, Texas, United States
MedSource, Inc
Chesapeake, Virginia, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
Seattle, Washington, United States
Beloit Clinic, SC
Beloit, Wisconsin, United States
Dean/Riverview Clinic
Janesville, Wisconsin, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Heart Health Institute
Calgary, Alberta, Canada
Heart Health Research Center
Calgary, Alberta, Canada
University of Calgary
Calgary, Alberta, Canada
Cardiology Research St. Paul's Hospital
Vancouver, British Columbia, Canada
Neureka Research Corporation
Greater Sudbury, Ontario, Canada
Hamilton Health Science Corp.
Hamilton, Ontario, Canada
Cardiac Investigation Unit
London, Ontario, Canada
Niagara Health System Greater Niagara General Hospital
Niagara Falls, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Recharche Cardiologie
Montreal, Quebec, Canada
Chum Hotel Dieu
Montreal, Quebec, Canada
Hospital Sacre-Soeur de Montreal
Montreal, Quebec, Canada
Quebec Heart Institute
Sainte-Foy, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2000037
Identifier Type: -
Identifier Source: org_study_id