Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
Sponsor
Forest Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT00035464
Collaborator
(none)
431
103
2
37
4.2
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
431 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
Study Start Date
:
Dec 1, 2000
Actual Primary Completion Date
:
Jan 1, 2004
Actual Study Completion Date
:
Jan 1, 2004
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 1 Placebo tablets |
Drug: Placebo
placebo tablets, twice a day for 6 months
|
| Experimental: 2 125 mg azimilide tablets |
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
|
Outcome Measures
Primary Outcome Measures
- To prolong the tachycardia-free period in patients [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiovascular Assoc. PC | Birmingham | Alabama | United States | 35213 |
| 2 | The Heart Group, PC | Mobile | Alabama | United States | 36608 |
| 3 | Southern Arizona VA Health Care System, Section of Cardiology (1-111C) | Tucson | Arizona | United States | 85723 |
| 4 | University Medical Center | Tucson | Arizona | United States | 85742 |
| 5 | University of Arkansas Medical Center | Little Rock | Arkansas | United States | 72205 |
| 6 | Cardiovascular Associates of Penisula | Burlingame | California | United States | 94010 |
| 7 | Capitol Interventional Cardiology | Carmichael | California | United States | 95608 |
| 8 | VA Central California Health Care System | Fresno | California | United States | 93703 |
| 9 | Valley Research | Fresno | California | United States | 93720 |
| 10 | Grass Valley Cardiology | Grass Valley | California | United States | 95945 |
| 11 | San Diego Cardiovascular Associates | La Jolla | California | United States | 92037 |
| 12 | Good Samaritan Hospital | Los Angeles | California | United States | 90017 |
| 13 | LAC+USC Medical Center | Los Angeles | California | United States | 90033 |
| 14 | Cardiology Section, West Los Angeles VA Hospital | Los Angeles | California | United States | 90073 |
| 15 | Merced Heart Associates | Merced | California | United States | 95340 |
| 16 | Sutter Gould Medical Foundation | Modesto | California | United States | 95355 |
| 17 | ARI Clinical Trials | Redondo Beach | California | United States | 90277 |
| 18 | Regional Cardiology Assoc. | Sacramento | California | United States | 95819 |
| 19 | Sacramento Heart and Vascular Medical Associates | Sacramento | California | United States | 95825 |
| 20 | Cardiology Associates | San Diego | California | United States | 92120 |
| 21 | Aurora Denver Cardiology | Aurora | Colorado | United States | 80012 |
| 22 | Western Cardiology Assoc. | Denver | Colorado | United States | 80218 |
| 23 | Hartford Hospital | Hartford | Connecticut | United States | 06102 |
| 24 | The George Washington University MFA | Washington | District of Columbia | United States | 20037 |
| 25 | Cardiology Consultants | Daytona Beach | Florida | United States | 32114 |
| 26 | C/O Research Office Attn: Cardiovascular Research Dept. | Fort Lauderdale | Florida | United States | 33316 |
| 27 | SW Florida Heart Group/Health Park Medical Center | Ft. Myers | Florida | United States | 33919 |
| 28 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 29 | Watson Clinic, LLP | Lakeland | Florida | United States | 33805 |
| 30 | Khalid Hassan Sheikh 80 Fontenberry Road | Merritt Island | Florida | United States | 32952 |
| 31 | Florida Cardiology | Orlando | Florida | United States | 32803 |
| 32 | Cardiology Research Assiocates | Ormond Beach | Florida | United States | 32174 |
| 33 | VA Medical Center | Decatur | Georgia | United States | 30033 |
| 34 | Mount Sinal Hospital Medical Center | Chicago | Illinois | United States | 60608 |
| 35 | Elgin Cardiology Associates | Elgin | Illinois | United States | 60120 |
| 36 | Illinois Heart & Lung Research Center, SC | Normal | Illinois | United States | 61761-3587 |
| 37 | The Center for Advanced Cardiology | Park Ridge | Illinois | United States | 60068 |
| 38 | Heart Center Medical Group | Ft. Wayne | Indiana | United States | 46804 |
| 39 | The Care Group | Indianapolis | Indiana | United States | 46260-1919 |
| 40 | Professional Research Network of Kansas | Wichita | Kansas | United States | 67203 |
| 41 | University of Louisville-Cardiology | Louisville | Kentucky | United States | 40202 |
| 42 | Louisville Cardiology Medical Group, P.S.C | Louisville | Kentucky | United States | 40207 |
| 43 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 44 | Richard Gilmore, MD 501 S Ryan Street | Lake Charles | Louisiana | United States | 70601 |
| 45 | Cardiovascular of the South | Morgan City | Louisiana | United States | 70380 |
| 46 | Cardiovascular Institute of the South | New Iberia | Louisiana | United States | 70560 |
| 47 | Tulane University | New Orleans | Louisiana | United States | 70112 |
| 48 | Medical Research Institute | Slidell | Louisiana | United States | 70458 |
| 49 | Cardiovascular Institute of the South | Thibodaux | Louisiana | United States | 70301 |
| 50 | Maine Medical Center | Portland | Maine | United States | 04102 |
| 51 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 52 | University of Massachusett | Worcester | Massachusetts | United States | 01655 |
| 53 | Thoracic & Cardiovascular Healthcare Foundation | Lansing | Michigan | United States | 48910 |
| 54 | Nisus Research | Petoskey | Michigan | United States | 49770 |
| 55 | Riverside Osteopathic Hospital | Trenton | Michigan | United States | 48183 |
| 56 | VA Medical Center Therapeutic Section | :Minneapolis | Minnesota | United States | 55417 |
| 57 | Regional Heart Center | Duluth | Minnesota | United States | 55802 |
| 58 | Fairview Range Regional Health Services | Hibbing | Minnesota | United States | 55746 |
| 59 | St. Patrick Hosp/Western Mt. Clinic Cardiology | Missoula | Montana | United States | 59802 |
| 60 | Internal Medical Associates | Grand Island | Nebraska | United States | 68803 |
| 61 | William Olney, MD 21 Whitehall Rd, Suite 200 | Rochester | New Hampshire | United States | 03867 |
| 62 | Cardiology & Int. Medicine | Williamsville | New York | United States | 14221 |
| 63 | Duke Medical Center | Durham | North Carolina | United States | 27710 |
| 64 | Altru Health System Research Center | Grand Forks | North Dakota | United States | 58201 |
| 65 | Lindner Clinical Trial Ctr. | Cincinnati | Ohio | United States | 45219 |
| 66 | University Hospitals of Cleveland | Cleveland | Ohio | United States | 44106-5038 |
| 67 | MidWest Cardiology Research Foundation | Columbus | Ohio | United States | 43214 |
| 68 | Oklahoma Foundation for Cardiovascular Research | Oklahoma City | Oklahoma | United States | 73104 |
| 69 | Hillsboro Cardiology | Hillsboro | Oregon | United States | 97123 |
| 70 | Oregon Health Sciences University | Portland | Oregon | United States | 97201 |
| 71 | Heart Care Group PC | Allentown | Pennsylvania | United States | 18106-0880 |
| 72 | Tri-State Medical Group Cardiology | Beaver | Pennsylvania | United States | 15009 |
| 73 | Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 74 | The Pavillion | Jenkintown | Pennsylvania | United States | 19046 |
| 75 | UPHS/Presbyterian Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
| 76 | Cardiovascular and Critical Care Associates, P.C. | Pittsburgh | Pennsylvania | United States | 15224 |
| 77 | Charleston Cardiology | Charleston | South Carolina | United States | 29403 |
| 78 | Stern Cardiovascular Center Research Department | Memphis | Tennessee | United States | 38120 |
| 79 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390-9047 |
| 80 | Methodist Hospital | Houston | Texas | United States | 77030 |
| 81 | Heart and Vascular Inst. of Texas, PA | San Antonio | Texas | United States | 78217 |
| 82 | MedSource, Inc | Chesapeake | Virginia | United States | 23321 |
| 83 | Riverside Regional Medical Center | Newport News | Virginia | United States | 23601 |
| 84 | Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401 | Seattle | Washington | United States | 95165 |
| 85 | Beloit Clinic, SC | Beloit | Wisconsin | United States | 53511 |
| 86 | Dean/Riverview Clinic | Janesville | Wisconsin | United States | 53547-0551 |
| 87 | University of Wisconsin Madison | Madison | Wisconsin | United States | 53792 |
| 88 | Marshfield Clinic | Marshfield | Wisconsin | United States | 54449 |
| 89 | Heart Health Institute | Calgary | Alberta | Canada | T2E7C5 |
| 90 | Heart Health Research Center | Calgary | Alberta | Canada | T2E7C5 |
| 91 | University of Calgary | Calgary | Alberta | Canada | T2N4N1 |
| 92 | Cardiology Research St. Paul's Hospital | Vancouver | British Columbia | Canada | V6Z1Y6 |
| 93 | Hamilton Health Science Corp. | Hamilton | Ontario | Canada | L8L2X2 |
| 94 | Cardiac Investigation Unit | London | Ontario | Canada | N6A5A5 |
| 95 | Niagara Health System Greater Niagara General Hospital | Niagara Falls | Ontario | Canada | L2E7H1 |
| 96 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y4W7 |
| 97 | Neureka Research Corporation | Sudbury | Ontario | Canada | P3E6B4 |
| 98 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B1W6 |
| 99 | Montreal Heart Institute | Montreal | Quebec | Canada | H1T1C8 |
| 100 | Recharche Cardiologie | Montreal | Quebec | Canada | H2L4M1 |
| 101 | Chum Hotel Dieu | Montreal | Quebec | Canada | H2WIT8 |
| 102 | Hospital Sacre-Soeur de Montreal | Montreal | Quebec | Canada | H4J1C5 |
| 103 | Quebec Heart Institute | Sainte-Foy | Quebec | Canada | G1V4G5 |
Sponsors and Collaborators
- Forest Laboratories
Investigators
- Study Director: Martin Phillips, MD, Procter and Gamble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00035464
Other Study ID Numbers:
- 2000037
First Posted:
May 6, 2002
Last Update Posted:
Oct 3, 2011
Last Verified:
Sep 1, 2011