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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Azimilide Dihydrochloride
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular Assoc. PC
  • The Heart Group, PC
  • Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
  • University Medical Center
  • University of Arkansas Medical Center
  • Cardiovascular Associates of Penisula
  • Capitol Interventional Cardiology
  • VA Central California Health Care System
  • Valley Research
  • Grass Valley Cardiology
  • San Diego Cardiovascular Associates
  • Good Samaritan Hospital
  • LAC+USC Medical Center
  • Cardiology Section, West Los Angeles VA Hospital
  • Merced Heart Associates
  • Sutter Gould Medical Foundation
  • ARI Clinical Trials
  • Regional Cardiology Assoc.
  • Sacramento Heart and Vascular Medical Associates
  • Cardiology Associates
  • Aurora Denver Cardiology
  • Western Cardiology Assoc.
  • Hartford Hospital
  • The George Washington University MFA
  • Cardiology Consultants
  • C/O Research Office Attn: Cardiovascular Research Dept.
  • SW Florida Heart Group/Health Park Medical Center
  • Jacksonville Center for Clinical Research
  • Watson Clinic, LLP
  • Khalid Hassan Sheikh 80 Fontenberry Road
  • Florida Cardiology
  • Cardiology Research Assiocates
  • VA Medical Center
  • Mount Sinal Hospital Medical Center
  • Elgin Cardiology Associates
  • Illinois Heart & Lung Research Center, SC
  • The Center for Advanced Cardiology
  • Heart Center Medical Group
  • The Care Group
  • Professional Research Network of Kansas
  • University of Louisville-Cardiology
  • Louisville Cardiology Medical Group, P.S.C
  • Cardiovascular Institute of the South
  • Richard Gilmore, MD 501 S Ryan Street
  • Cardiovascular of the South
  • Cardiovascular Institute of the South
  • Tulane University
  • Medical Research Institute
  • Cardiovascular Institute of the South
  • Maine Medical Center
  • Boston Medical Center
  • University of Massachusett
  • Thoracic & Cardiovascular Healthcare Foundation
  • Nisus Research
  • Riverside Osteopathic Hospital
  • VA Medical Center Therapeutic Section
  • Regional Heart Center
  • Fairview Range Regional Health Services
  • St. Patrick Hosp/Western Mt. Clinic Cardiology
  • Internal Medical Associates
  • William Olney, MD 21 Whitehall Rd, Suite 200
  • Cardiology & Int. Medicine
  • Duke Medical Center
  • Altru Health System Research Center
  • Lindner Clinical Trial Ctr.
  • University Hospitals of Cleveland
  • MidWest Cardiology Research Foundation
  • Oklahoma Foundation for Cardiovascular Research
  • Hillsboro Cardiology
  • Oregon Health Sciences University
  • Heart Care Group PC
  • Tri-State Medical Group Cardiology
  • Milton S. Hershey Medical Center
  • The Pavillion
  • UPHS/Presbyterian Medical Center
  • Cardiovascular and Critical Care Associates, P.C.
  • Charleston Cardiology
  • Stern Cardiovascular Center Research Department
  • UT Southwestern Medical Center
  • Methodist Hospital
  • Heart and Vascular Inst. of Texas, PA
  • MedSource, Inc
  • Riverside Regional Medical Center
  • Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
  • Beloit Clinic, SC
  • Dean/Riverview Clinic
  • University of Wisconsin Madison
  • Marshfield Clinic
  • Heart Health Institute
  • Heart Health Research Center
  • University of Calgary
  • Cardiology Research St. Paul's Hospital
  • Hamilton Health Science Corp.
  • Cardiac Investigation Unit
  • Niagara Health System Greater Niagara General Hospital
  • University of Ottawa Heart Institute
  • Neureka Research Corporation
  • St. Michael's Hospital
  • Montreal Heart Institute
  • Recharche Cardiologie
  • Chum Hotel Dieu
  • Hospital Sacre-Soeur de Montreal
  • Quebec Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo tablets

125 mg azimilide tablets

Outcomes

Primary Outcome Measures

To prolong the tachycardia-free period in patients

Secondary Outcome Measures

Full Information

First Posted
May 3, 2002
Last Updated
September 30, 2011
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00035464
Brief Title
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
Official Title
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Arm Title
2
Arm Type
Experimental
Arm Description
125 mg azimilide tablets
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
125 mg azimilide tablets, twice a day for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets, twice a day for 6 months
Primary Outcome Measure Information:
Title
To prolong the tachycardia-free period in patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Phillips, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Cardiovascular Assoc. PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
The Heart Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Southern Arizona VA Health Care System, Section of Cardiology (1-111C)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85742
Country
United States
Facility Name
University of Arkansas Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cardiovascular Associates of Penisula
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Capitol Interventional Cardiology
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
VA Central California Health Care System
City
Fresno
State/Province
California
ZIP/Postal Code
93703
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Grass Valley Cardiology
City
Grass Valley
State/Province
California
ZIP/Postal Code
95945
Country
United States
Facility Name
San Diego Cardiovascular Associates
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cardiology Section, West Los Angeles VA Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Merced Heart Associates
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Sutter Gould Medical Foundation
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
ARI Clinical Trials
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Regional Cardiology Assoc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sacramento Heart and Vascular Medical Associates
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Cardiology Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Aurora Denver Cardiology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Western Cardiology Assoc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
The George Washington University MFA
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Cardiology Consultants
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
C/O Research Office Attn: Cardiovascular Research Dept.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
SW Florida Heart Group/Health Park Medical Center
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Watson Clinic, LLP
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Khalid Hassan Sheikh 80 Fontenberry Road
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Florida Cardiology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Cardiology Research Assiocates
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Mount Sinal Hospital Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Elgin Cardiology Associates
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60120
Country
United States
Facility Name
Illinois Heart & Lung Research Center, SC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761-3587
Country
United States
Facility Name
The Center for Advanced Cardiology
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Heart Center Medical Group
City
Ft. Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
The Care Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260-1919
Country
United States
Facility Name
Professional Research Network of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
University of Louisville-Cardiology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Louisville Cardiology Medical Group, P.S.C
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Richard Gilmore, MD 501 S Ryan Street
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Cardiovascular of the South
City
Morgan City
State/Province
Louisiana
ZIP/Postal Code
70380
Country
United States
Facility Name
Cardiovascular Institute of the South
City
New Iberia
State/Province
Louisiana
ZIP/Postal Code
70560
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Thibodaux
State/Province
Louisiana
ZIP/Postal Code
70301
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
University of Massachusett
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Thoracic & Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Nisus Research
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Riverside Osteopathic Hospital
City
Trenton
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
VA Medical Center Therapeutic Section
City
:Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Regional Heart Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55802
Country
United States
Facility Name
Fairview Range Regional Health Services
City
Hibbing
State/Province
Minnesota
ZIP/Postal Code
55746
Country
United States
Facility Name
St. Patrick Hosp/Western Mt. Clinic Cardiology
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Internal Medical Associates
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
William Olney, MD 21 Whitehall Rd, Suite 200
City
Rochester
State/Province
New Hampshire
ZIP/Postal Code
03867
Country
United States
Facility Name
Cardiology & Int. Medicine
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Altru Health System Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Lindner Clinical Trial Ctr.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5038
Country
United States
Facility Name
MidWest Cardiology Research Foundation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Foundation for Cardiovascular Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hillsboro Cardiology
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Heart Care Group PC
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18106-0880
Country
United States
Facility Name
Tri-State Medical Group Cardiology
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
The Pavillion
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
UPHS/Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Cardiovascular and Critical Care Associates, P.C.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Charleston Cardiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Stern Cardiovascular Center Research Department
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9047
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Heart and Vascular Inst. of Texas, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
MedSource, Inc
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401
City
Seattle
State/Province
Washington
ZIP/Postal Code
95165
Country
United States
Facility Name
Beloit Clinic, SC
City
Beloit
State/Province
Wisconsin
ZIP/Postal Code
53511
Country
United States
Facility Name
Dean/Riverview Clinic
City
Janesville
State/Province
Wisconsin
ZIP/Postal Code
53547-0551
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Heart Health Institute
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E7C5
Country
Canada
Facility Name
Heart Health Research Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E7C5
Country
Canada
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
Cardiology Research St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Hamilton Health Science Corp.
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
Cardiac Investigation Unit
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Niagara Health System Greater Niagara General Hospital
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2E7H1
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4W7
Country
Canada
Facility Name
Neureka Research Corporation
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E6B4
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W6
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada
Facility Name
Recharche Cardiologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
Chum Hotel Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2WIT8
Country
Canada
Facility Name
Hospital Sacre-Soeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J1C5
Country
Canada
Facility Name
Quebec Heart Institute
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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