|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Procter and Gamble |
|---|---|
| Information provided by: | Procter and Gamble |
| ClinicalTrials.gov Identifier: | NCT00035464 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: Azimilide Dihydrochloride Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients |
| Enrollment: | 431 |
| Study Start Date: | December 2000 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Placebo tablets
|
Drug: Placebo
placebo tablets, twice a day for 6 months
|
|
2: Experimental
125 mg azimilide tablets
|
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Cardiovascular Assoc. PC | |
| Birmingham, Alabama, United States, 35213 | |
| The Heart Group, PC | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Southern Arizona VA Health Care System, Section of Cardiology (1-111C) | |
| Tucson, Arizona, United States, 85723 | |
| University Medical Center | |
| Tucson, Arizona, United States, 85742 | |
| United States, Arkansas | |
| University of Arkansas Medical Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Capitol Interventional Cardiology | |
| Carmichael, California, United States, 95608 | |
| Good Samaritan Hospital | |
| Los Angeles, California, United States, 90017 | |
| VA Central California Health Care System | |
| Fresno, California, United States, 93703 | |
| San Diego Cardiovascular Associates | |
| La Jolla, California, United States, 92037 | |
| Sacramento Heart and Vascular Medical Associates | |
| Sacramento, California, United States, 95825 | |
| Valley Research | |
| Fresno, California, United States, 93720 | |
| Grass Valley Cardiology | |
| Grass Valley, California, United States, 95945 | |
| LAC+USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| ARI Clinical Trials | |
| Redondo Beach, California, United States, 90277 | |
| Merced Heart Associates | |
| Merced, California, United States, 95340 | |
| Cardiovascular Associates of Penisula | |
| Burlingame, California, United States, 94010 | |
| Cardiology Associates | |
| San Diego, California, United States, 92120 | |
| Sutter Gould Medical Foundation | |
| Modesto, California, United States, 95355 | |
| Cardiology Section, West Los Angeles VA Hospital | |
| Los Angeles, California, United States, 90073 | |
| Regional Cardiology Assoc. | |
| Sacramento, California, United States, 95819 | |
| United States, Colorado | |
| Aurora Denver Cardiology | |
| Aurora, Colorado, United States, 80012 | |
| Western Cardiology Assoc. | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| United States, District of Columbia | |
| The George Washington University MFA | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Watson Clinic, LLP | |
| Lakeland, Florida, United States, 33805 | |
| SW Florida Heart Group/Health Park Medical Center | |
| Ft. Myers, Florida, United States, 33919 | |
| Cardiology Research Assiocates | |
| Ormond Beach, Florida, United States, 32174 | |
| Cardiology Consultants | |
| Daytona Beach, Florida, United States, 32114 | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Khalid Hassan Sheikh 80 Fontenberry Road | |
| Merritt Island, Florida, United States, 32952 | |
| C/O Research Office Attn: Cardiovascular Research Dept. | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Florida Cardiology | |
| Orlando, Florida, United States, 32803 | |
| United States, Georgia | |
| VA Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| The Center for Advanced Cardiology | |
| Park Ridge, Illinois, United States, 60068 | |
| Mount Sinal Hospital Medical Center | |
| Chicago, Illinois, United States, 60608 | |
| Illinois Heart & Lung Research Center, SC | |
| Normal, Illinois, United States, 61761-3587 | |
| Elgin Cardiology Associates | |
| Elgin, Illinois, United States, 60120 | |
| United States, Indiana | |
| Heart Center Medical Group | |
| Ft. Wayne, Indiana, United States, 46804 | |
| The Care Group | |
| Indianapolis, Indiana, United States, 46260-1919 | |
| United States, Kansas | |
| Professional Research Network of Kansas | |
| Wichita, Kansas, United States, 67203 | |
| United States, Kentucky | |
| Louisville Cardiology Medical Group, P.S.C | |
| Louisville, Kentucky, United States, 40207 | |
| University of Louisville-Cardiology | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Medical Research Institute | |
| Slidell, Louisiana, United States, 70458 | |
| Cardiovascular Institute of the South | |
| Thibodaux, Louisiana, United States, 70301 | |
| Cardiovascular Institute of the South | |
| New Iberia, Louisiana, United States, 70560 | |
| Cardiovascular Institute of the South | |
| Houma, Louisiana, United States, 70360 | |
| Cardiovascular of the South | |
| Morgan City, Louisiana, United States, 70380 | |
| Richard Gilmore, MD 501 S Ryan Street | |
| Lake Charles, Louisiana, United States, 70601 | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| University of Massachusett | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Nisus Research | |
| Petoskey, Michigan, United States, 49770 | |
| Thoracic & Cardiovascular Healthcare Foundation | |
| Lansing, Michigan, United States, 48910 | |
| Riverside Osteopathic Hospital | |
| Trenton, Michigan, United States, 48183 | |
| United States, Minnesota | |
| Regional Heart Center | |
| Duluth, Minnesota, United States | |
| VA Medical Center Therapeutic Section | |
| :Minneapolis, Minnesota, United States, 55417 | |
| Fairview Range Regional Health Services | |
| Hibbing, Minnesota, United States, 55746 | |
| United States, Montana | |
| St. Patrick Hosp/Western Mt. Clinic Cardiology | |
| Missoula, Montana, United States, 59802 | |
| United States, Nebraska | |
| Internal Medical Associates | |
| Grand Island, Nebraska, United States, 68803 | |
| United States, New Hampshire | |
| William Olney, MD 21 Whitehall Rd, Suite 200 | |
| Rochester, New Hampshire, United States, 03867 | |
| United States, New York | |
| Cardiology & Int. Medicine | |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Duke Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, North Dakota | |
| Altru Health System Research Center | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| MidWest Cardiology Research Foundation | |
| Columbus, Ohio, United States, 43214 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106-5038 | |
| Lindner Clinical Trial Ctr. | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oklahoma | |
| Oklahoma Foundation for Cardiovascular Research | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201 | |
| Hillsboro Cardiology | |
| Hillsboro, Oregon, United States, 97123 | |
| United States, Pennsylvania | |
| Cardiovascular and Critical Care Associates, P.C. | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| The Pavillion | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Heart Care Group PC | |
| Allentown, Pennsylvania, United States, 18106-0880 | |
| UPHS/Presbyterian Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Tri-State Medical Group Cardiology | |
| Beaver, Pennsylvania, United States, 15009 | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Carolina | |
| Charleston Cardiology | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| Stern Cardiovascular Center Research Department | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Heart and Vascular Inst. of Texas, PA | |
| San Antonio, Texas, United States, 78217 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390-9047 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| MedSource, Inc | |
| Chesapeake, Virginia, United States, 23321 | |
| Riverside Regional Medical Center | |
| Newport News, Virginia, United States, 23601 | |
| United States, Washington | |
| Daniel Gottlieb, MD 16259 Sylvester Road SW, Suite 401 | |
| Seattle, Washington, United States, 95165 | |
| United States, Wisconsin | |
| Marshfield Clinic | |
| Marshfield, Wisconsin, United States, 54449 | |
| Beloit Clinic, SC | |
| Beloit, Wisconsin, United States, 53511 | |
| University of Wisconsin Madison | |
| Madison, Wisconsin, United States, 53792 | |
| Dean/Riverview Clinic | |
| Janesville, Wisconsin, United States, 53547-0551 | |
| Canada, Alberta | |
| Heart Health Research Center | |
| Calgary, Alberta, Canada, T2E7C5 | |
| Heart Health Institute | |
| Calgary, Alberta, Canada, T2E7C5 | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N4N1 | |
| Canada, British Columbia | |
| Cardiology Research St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z1Y6 | |
| Canada, Ontario | |
| Niagara Health System Greater Niagara General Hospital | |
| Niagara Falls, Ontario, Canada, L2E7H1 | |
| Hamilton Health Science Corp. | |
| Hamilton, Ontario, Canada, L8L2X2 | |
| Neureka Research Corporation | |
| Sudbury, Ontario, Canada, P3E6B4 | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y4W7 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B1W6 | |
| Cardiac Investigation Unit | |
| London, Ontario, Canada, N6A5A5 | |
| Canada, Quebec | |
| Chum Hotel Dieu | |
| Montreal, Quebec, Canada, H2WIT8 | |
| Recharche Cardiologie | |
| Montreal, Quebec, Canada, H2L4M1 | |
| Hospital Sacre-Soeur de Montreal | |
| Montreal, Quebec, Canada, H4J1C5 | |
| Quebec Heart Institute | |
| Sainte-Foy, Quebec, Canada, G1V4G5 | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T1C8 | |
| Study Director: | Martin Phillips, MD | Procter and Gamble |
More Information
| Responsible Party: | Procter & Gamble Pharmaceuticals ( Martin Phillips, MD ) |
| Study ID Numbers: | 2000037 |
| Study First Received: | May 3, 2002 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00035464 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Heart Diseases Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Azimilide Membrane Transport Modulators |
Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |