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

NCT00035464 | Completed Phase 3

• 1 other identifier: 2000037
• Study Type: interventional
• Target: 431
• Locations: 2 countries
• Sites: 103

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• To prolong the tachycardia-free period in patients

  6 months

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

2

EXPERIMENTAL

125 mg azimilide tablets

Drug: Azimilide Dihydrochloride

Interventions

Azimilide Dihydrochloride DRUG

125 mg azimilide tablets, twice a day for 6 months

2

Placebo DRUG

placebo tablets, twice a day for 6 months

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (103)

Cardiovascular Assoc. PC

Birmingham, Alabama, 35213, United States

Location

The Heart Group, PC

Mobile, Alabama, 36608, United States

Location

Southern Arizona VA Health Care System, Section of Cardiology (1-111C)

Tucson, Arizona, 85723, United States

Location

University Medical Center

Tucson, Arizona, 85742, United States

Location

University of Arkansas Medical Center

Little Rock, Arkansas, 72205, United States

Location

Cardiovascular Associates of Penisula

Burlingame, California, 94010, United States

Location

Capitol Interventional Cardiology

Carmichael, California, 95608, United States

Location

VA Central California Health Care System

Fresno, California, 93703, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

Grass Valley Cardiology

Grass Valley, California, 95945, United States

Location

San Diego Cardiovascular Associates

La Jolla, California, 92037, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

Cardiology Section, West Los Angeles VA Hospital

Los Angeles, California, 90073, United States

Location

Merced Heart Associates

Merced, California, 95340, United States

Location

Sutter Gould Medical Foundation

Modesto, California, 95355, United States

Location

ARI Clinical Trials

Redondo Beach, California, 90277, United States

Location

Regional Cardiology Assoc.

Sacramento, California, 95819, United States

Location

Sacramento Heart and Vascular Medical Associates

Sacramento, California, 95825, United States

Location

Cardiology Associates

San Diego, California, 92120, United States

Location

Aurora Denver Cardiology

Aurora, Colorado, 80012, United States

Location

Western Cardiology Assoc.

Denver, Colorado, 80218, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

The George Washington University MFA

Washington D.C., District of Columbia, 20037, United States

Location

Cardiology Consultants

Daytona Beach, Florida, 32114, United States

Location

C/O Research Office Attn: Cardiovascular Research Dept.

Fort Lauderdale, Florida, 33316, United States

Location

SW Florida Heart Group/Health Park Medical Center

Fort Myers, Florida, 33919, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Watson Clinic, LLP

Lakeland, Florida, 33805, United States

Location

Khalid Hassan Sheikh 80 Fontenberry Road

Merritt Island, Florida, 32952, United States

Location

Florida Cardiology

Orlando, Florida, 32803, United States

Location

Cardiology Research Assiocates

Ormond Beach, Florida, 32174, United States

Location

VA Medical Center

Decatur, Georgia, 30033, United States

Location

Mount Sinal Hospital Medical Center

Chicago, Illinois, 60608, United States

Location

Elgin Cardiology Associates

Elgin, Illinois, 60120, United States

Location

Illinois Heart & Lung Research Center, SC

Normal, Illinois, 61761-3587, United States

Location

The Center for Advanced Cardiology

Park Ridge, Illinois, 60068, United States

Location

Heart Center Medical Group

Fort Wayne, Indiana, 46804, United States

Location

The Care Group

Indianapolis, Indiana, 46260-1919, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, 67203, United States

Location

University of Louisville-Cardiology

Louisville, Kentucky, 40202, United States

Location

Louisville Cardiology Medical Group, P.S.C

Louisville, Kentucky, 40207, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Richard Gilmore, MD 501 S Ryan Street

Lake Charles, Louisiana, 70601, United States

Location

Cardiovascular of the South

Morgan City, Louisiana, 70380, United States

Location

Cardiovascular Institute of the South

New Iberia, Louisiana, 70560, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Medical Research Institute

Slidell, Louisiana, 70458, United States

Location

Cardiovascular Institute of the South

Thibodaux, Louisiana, 70301, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusett

Worcester, Massachusetts, 01655, United States

Location

Thoracic & Cardiovascular Healthcare Foundation

Lansing, Michigan, 48910, United States

Location

Nisus Research

Petoskey, Michigan, 49770, United States

Location

Riverside Osteopathic Hospital

Trenton, Michigan, 48183, United States

Location

Regional Heart Center

Duluth, Minnesota, 55802, United States

Location

Fairview Range Regional Health Services

Hibbing, Minnesota, 55746, United States

Location

VA Medical Center Therapeutic Section

Minneapolis, Minnesota, 55417, United States

Location

St. Patrick Hosp/Western Mt. Clinic Cardiology

Missoula, Montana, 59802, United States

Location

Internal Medical Associates

Grand Island, Nebraska, 68803, United States

Location

William Olney, MD 21 Whitehall Rd, Suite 200

Rochester, New Hampshire, 03867, United States

Location

Cardiology & Int. Medicine

Williamsville, New York, 14221, United States

Location

Duke Medical Center

Durham, North Carolina, 27710, United States

Location

Altru Health System Research Center

Grand Forks, North Dakota, 58201, United States

Location

Lindner Clinical Trial Ctr.

Cincinnati, Ohio, 45219, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106-5038, United States

Location

MidWest Cardiology Research Foundation

Columbus, Ohio, 43214, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73104, United States

Location

Hillsboro Cardiology

Hillsboro, Oregon, 97123, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Heart Care Group PC

Allentown, Pennsylvania, 18106-0880, United States

Location

Tri-State Medical Group Cardiology

Beaver, Pennsylvania, 15009, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

The Pavillion

Jenkintown, Pennsylvania, 19046, United States

Location

UPHS/Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Cardiovascular and Critical Care Associates, P.C.

Pittsburgh, Pennsylvania, 15224, United States

Location

Charleston Cardiology

Charleston, South Carolina, 29403, United States

Location

Stern Cardiovascular Center Research Department

Memphis, Tennessee, 38120, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390-9047, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Heart and Vascular Inst. of Texas, PA

San Antonio, Texas, 78217, United States

Location

MedSource, Inc

Chesapeake, Virginia, 23321, United States

Location

Riverside Regional Medical Center

Newport News, Virginia, 23601, United States

Location

Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401

Seattle, Washington, 95165, United States

Location

Beloit Clinic, SC

Beloit, Wisconsin, 53511, United States

Location

Dean/Riverview Clinic

Janesville, Wisconsin, 53547-0551, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Heart Health Institute

Calgary, Alberta, T2E7C5, Canada

Location

Heart Health Research Center

Calgary, Alberta, T2E7C5, Canada

Location

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

Cardiology Research St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

Location

Neureka Research Corporation

Greater Sudbury, Ontario, P3E6B4, Canada

Location

Hamilton Health Science Corp.

Hamilton, Ontario, L8L2X2, Canada

Location

Cardiac Investigation Unit

London, Ontario, N6A5A5, Canada

Location

Niagara Health System Greater Niagara General Hospital

Niagara Falls, Ontario, L2E7H1, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W6, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T1C8, Canada

Location

Recharche Cardiologie

Montreal, Quebec, H2L4M1, Canada

Location

Chum Hotel Dieu

Montreal, Quebec, H2WIT8, Canada

Location

Hospital Sacre-Soeur de Montreal

Montreal, Quebec, H4J1C5, Canada

Location

Quebec Heart Institute

Sainte-Foy, Quebec, G1V4G5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

azimilide

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Phillips, MD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 3, 2002
• First Posted: May 6, 2002
• Study Start: December 1, 2000
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2004
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

CA (15); US (88)