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

Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00035477
Collaborator
(none)
446
Enrollment
82
Locations
2
Arms
37
Duration (Months)
5.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Azimilide Dihydrochloride
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
446 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
Study Start Date :
Sep 1, 2000
Actual Primary Completion Date :
Oct 1, 2003
Actual Study Completion Date :
Oct 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

placebo tablets in hospital and placebo tablets outpatient

Drug: Placebo
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
Experimental: 2

Azimilide tablets in hospital and azimilide tablets outpatient

Drug: Azimilide Dihydrochloride
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

Outcome Measures

Primary Outcome Measures

  1. Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Heart Group, PC Mobile Alabama United States 36608
2 University Medical Center Tucson Arizona United States 85742
3 Cardiovascular Associates of Penisula Burlingame California United States 94010
4 San Diego Cardiovascular Research Associates Encinitas California United States 92024
5 La Mesa Cardiac Center, a Medical Group La Mesa California United States 91942
6 Good Samaritan Hospital Los Angeles California United States 90017
7 LAC + USC Medical Center Los Angeles California United States 90033
8 Cardiology Section, West Los Angeles VA Hospital Los Angeles California United States 90073
9 Merced Heart Associates Merced California United States 95340
10 Sutter Gould Medical Foundation Modesto California United States 95335
11 ARI Clinical Trials Redondo Beach California United States 90277
12 Inland Clinical Research Riverside California United States 92501
13 Regional Cardiology Assoc. Sacramento California United States 95819
14 Cardiology Associates San Diego California United States 92120
15 Western Cardiology Assoc. Denver Colorado United States 80218
16 Hartford Hospital Hartford Connecticut United States 06102
17 The George Washington University MFA Washington District of Columbia United States 20037
18 Cardiology Consultants Daytona Beach Florida United States 32114
19 C/O Research Office Attn: Cardiovascular Research Dept. Fort Lauderdale Florida United States 33316
20 Jacksonville Center for Clinical Research Jacksonville Florida United States 32216
21 Lakeland Regional Medical Lakeland Florida United States 33805
22 Khalid Hasan Sheikh 80 Fortenberry Road Merritt Island Florida United States 32952
23 Florida Cardiology Orlando Florida United States 32803
24 Cardiology Reasearch Assiocates Ormond Beach Florida United States 32174
25 VA Medical Center Decatur Georgia United States 30033
26 Elgin Cardiology Associates Elgin Illinois United States 60120
27 Advocate Christ Medical Center Oak Lawn Illinois United States 60453
28 Heart Center Medical Group Ft. Wayne Indiana United States 46804
29 The Care Group Indianapolis Indiana United States 46260
30 University of Louisville-Cardiology Louisville Kentucky United States 40202
31 Louisville Cardiology Medical Group, P.S.C. Louisville Kentucky United States 40207
32 Cardiovascular Institute of the South Houma Louisiana United States 70360
33 Richard Gilmore 501 S. Ryan Street Lake Charles Louisiana United States 70601
34 Cardiovascular Instiute of the South Morgan City Louisiana United States 70380
35 Tulane University New Orleans Louisiana United States 70112
36 Androscoggin Cardiology Associates Research Auburn Maine United States 04201
37 Maine Medical Center Portland Maine United States 04102
38 University of Massachusett Worcester Massachusetts United States 01655
39 Thoracic & Cardiovascular Healthcare Foundation Lansing Michigan United States 48910
40 Riverside Osteopathic Hospital Trenton Michigan United States 48183
41 Regional Heart Center Duluth Minnesota United States 55805
42 VA Medical Center Therapeutic Section Minneapolis Minnesota United States 55417
43 St. Paul Heart Clinic St. Paul Minnesota United States 55102
44 Duke Medical Center Durham North Carolina United States 27710
45 Altru Health System Research Center Grand Forks North Dakota United States 58201
46 Lindner Clinical Trial Ctr. Cincinnati Ohio United States 45219
47 University Hospitals of Cleveland Cleveland Ohio United States 44106
48 Hillsboro Cardiology Hillsboro Oregon United States 97123
49 Oregon Health Sciences University Portland Oregon United States 97201
50 Heart Care Group PC Allentown Pennsylvania United States 18106
51 Tri-State Medical Group Cardiology Beaver Pennsylvania United States 15009
52 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
53 The Pavillion Jenkintown Pennsylvania United States 19046
54 UPHS/Presbyterian Medical Center Philadelphia Pennsylvania United States 19104
55 Cardiovascular and Critical Care Associates, P.C. Pittsburgh Pennsylvania United States 15224
56 Cardiology Foundation of Lankenau Wynnewood Pennsylvania United States 19096
57 Charleston Cardiology Charleston South Carolina United States 29403
58 Stern Cardiovascular Center Research Department Memphis Tennessee United States 38120
59 UT Southwestern Medical Center Dallas Texas United States 75390
60 Methodist Hospital Houston Texas United States 77030
61 Heart and Vascular Inst. of Texas, PA San Antonio Texas United States 78217
62 Riverside Regional Medical Center Newport News Virginia United States 23601
63 Daniel Gottlieb 16259 Sylvester Road SW Suite 401 Seattle Washington United States 98166
64 FHS Research Tacoma Washington United States 98405
65 Beloit Clinic, SC Beloit Wisconsin United States 53511
66 Wisconsin Center for Clinical Research Elkhorn Wisconsin United States 53121
67 Dean/Riverview Clinic Janesville Wisconsin United States 53547
68 University of Wisconsin Madison Madison Wisconsin United States 53792
69 Wisconsin Center for Clinical Research Milwaukee Wisconsin United States 53251
70 University of Calgary Calgary Alberta Canada T2N 4N1
71 Rockyview General Hospital CV Lab Research Calgary Alberta Canada T2V 1P9
72 Cardiology Research St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6
73 Health Sciences Centre Winnipeg Manitoba Canada R3E0Z3
74 Hamilton Health Sciences Crop Hamilton Ontario Canada L8L 2X2
75 Cardiac Investigation Unit London Ontario Canada N6A 5A5
76 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7
77 Neureka Research Corporation Sudbury Ontario Canada P3E6B4
78 St. Michael's Hospital Toronto Ontario Canada M5B 1W8
79 Montreal Heart Institute Montreal Quebec Canada H1T1C8
80 Recherche Cardiologie Montreal Quebec Canada H2L4M1
81 Hospital Sacre-Coeur de Montreal Montreal Quebec Canada H4J1C5
82 Quebec Heart Institute Sainte-Foy Quebec Canada G1V4G5

Sponsors and Collaborators

  • Forest Laboratories

Investigators

  • Study Director: Preston M Dunnmon, MD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00035477
Other Study ID Numbers:
  • 2000038
First Posted:
May 6, 2002
Last Update Posted:
Oct 3, 2011
Last Verified:
Sep 1, 2011
Additional relevant MeSH terms:
Atrial Fibrillation
Azimilide

Study Results

No Results Posted as of Oct 3, 2011