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Efficacy and Safety of Azimilide for the 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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening Require the procedure of cardioversion (electric shock to correct heart rhythm) In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion. Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines. Exclusion criteria: Previously unsuccessful electrical cardioversions 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

Sites / Locations

  • The Heart Group, PC
  • University Medical Center
  • Cardiovascular Associates of Penisula
  • San Diego Cardiovascular Research Associates
  • La Mesa Cardiac Center, a Medical Group
  • Good Samaritan Hospital
  • LAC + USC Medical Center
  • Cardiology Section, West Los Angeles VA Hospital
  • Merced Heart Associates
  • Sutter Gould Medical Foundation
  • ARI Clinical Trials
  • Inland Clinical Research
  • Regional Cardiology Assoc.
  • Cardiology Associates
  • Western Cardiology Assoc.
  • Hartford Hospital
  • The George Washington University MFA
  • Cardiology Consultants
  • C/O Research Office Attn: Cardiovascular Research Dept.
  • Jacksonville Center for Clinical Research
  • Lakeland Regional Medical
  • Khalid Hasan Sheikh 80 Fortenberry Road
  • Florida Cardiology
  • Cardiology Reasearch Assiocates
  • VA Medical Center
  • Elgin Cardiology Associates
  • Advocate Christ Medical Center
  • Heart Center Medical Group
  • The Care Group
  • University of Louisville-Cardiology
  • Louisville Cardiology Medical Group, P.S.C.
  • Cardiovascular Institute of the South
  • Richard Gilmore 501 S. Ryan Street
  • Cardiovascular Instiute of the South
  • Tulane University
  • Androscoggin Cardiology Associates Research
  • Maine Medical Center
  • University of Massachusett
  • Thoracic & Cardiovascular Healthcare Foundation
  • Riverside Osteopathic Hospital
  • Regional Heart Center
  • VA Medical Center Therapeutic Section
  • St. Paul Heart Clinic
  • Duke Medical Center
  • Altru Health System Research Center
  • Lindner Clinical Trial Ctr.
  • University Hospitals of Cleveland
  • 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.
  • Cardiology Foundation of Lankenau
  • Charleston Cardiology
  • Stern Cardiovascular Center Research Department
  • UT Southwestern Medical Center
  • Methodist Hospital
  • Heart and Vascular Inst. of Texas, PA
  • Riverside Regional Medical Center
  • Daniel Gottlieb 16259 Sylvester Road SW Suite 401
  • FHS Research
  • Beloit Clinic, SC
  • Wisconsin Center for Clinical Research
  • Dean/Riverview Clinic
  • University of Wisconsin Madison
  • Wisconsin Center for Clinical Research
  • University of Calgary
  • Rockyview General Hospital CV Lab Research
  • Cardiology Research St. Paul's Hospital
  • Health Sciences Centre
  • Hamilton Health Sciences Crop
  • Cardiac Investigation Unit
  • University of Ottawa Heart Institute
  • Neureka Research Corporation
  • St. Michael's Hospital
  • Montreal Heart Institute
  • Recherche Cardiologie
  • Hospital Sacre-Coeur 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 in hospital and placebo tablets outpatient

Azimilide tablets in hospital and azimilide tablets outpatient

Outcomes

Primary Outcome Measures

Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc

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
NCT00035477
Brief Title
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Official Title
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (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 maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. 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 to the study. This follow-up phase will continue 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
446 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
placebo tablets in hospital and placebo tablets outpatient
Arm Title
2
Arm Type
Experimental
Arm Description
Azimilide tablets in hospital and azimilide tablets outpatient
Intervention Type
Drug
Intervention Name(s)
Azimilide Dihydrochloride
Intervention Description
125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Primary Outcome Measure Information:
Title
Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening Require the procedure of cardioversion (electric shock to correct heart rhythm) In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion. Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines. Exclusion criteria: Previously unsuccessful electrical cardioversions 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preston M Dunnmon, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
The Heart Group, PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85742
Country
United States
Facility Name
Cardiovascular Associates of Penisula
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
San Diego Cardiovascular Research Associates
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
La Mesa Cardiac Center, a Medical Group
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
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
95335
Country
United States
Facility Name
ARI Clinical Trials
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Inland Clinical Research
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Regional Cardiology Assoc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Cardiology Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92120
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
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Lakeland Regional Medical
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Khalid Hasan Sheikh 80 Fortenberry 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 Reasearch 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
Elgin Cardiology Associates
City
Elgin
State/Province
Illinois
ZIP/Postal Code
60120
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
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
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 501 S. Ryan Street
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Cardiovascular Instiute of the South
City
Morgan City
State/Province
Louisiana
ZIP/Postal Code
70380
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Androscoggin Cardiology Associates Research
City
Auburn
State/Province
Maine
ZIP/Postal Code
04201
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
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
Riverside Osteopathic Hospital
City
Trenton
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Regional Heart Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
VA Medical Center Therapeutic Section
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
St. Paul Heart Clinic
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
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
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
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
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
Cardiology Foundation of Lankenau
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
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
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
Riverside Regional Medical Center
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Daniel Gottlieb 16259 Sylvester Road SW Suite 401
City
Seattle
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
FHS Research
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Beloit Clinic, SC
City
Beloit
State/Province
Wisconsin
ZIP/Postal Code
53511
Country
United States
Facility Name
Wisconsin Center for Clinical Research
City
Elkhorn
State/Province
Wisconsin
ZIP/Postal Code
53121
Country
United States
Facility Name
Dean/Riverview Clinic
City
Janesville
State/Province
Wisconsin
ZIP/Postal Code
53547
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Wisconsin Center for Clinical Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53251
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Rockyview General Hospital CV Lab Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Cardiology Research St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0Z3
Country
Canada
Facility Name
Hamilton Health Sciences Crop
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Cardiac Investigation Unit
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
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
M5B 1W8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada
Facility Name
Recherche Cardiologie
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
Hospital Sacre-Coeur 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

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Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

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