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| Sponsor: | Procter and Gamble |
|---|---|
| Information provided by: | Procter and Gamble |
| ClinicalTrials.gov Identifier: | NCT00035477 |
Purpose
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 | 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 for the Treatment of Patients With Atrial Fibrillation |
| Enrollment: | 446 |
| Study Start Date: | September 2000 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
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
|
|
2: Experimental
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| The Heart Group, PC | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| University Medical Center | |
| Tucson, Arizona, United States, 85742 | |
| United States, California | |
| Inland Clinical Research | |
| Riverside, California, United States, 92501 | |
| San Diego Cardiovascular Research Associates | |
| Encinitas, California, United States, 92024 | |
| La Mesa Cardiac Center, a Medical Group | |
| La Mesa, California, United States, 91942 | |
| Cardiovascular Associates of Penisula | |
| Burlingame, California, United States, 94010 | |
| 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 | |
| Good Samaritan Hospital | |
| Los Angeles, California, United States, 90017 | |
| Cardiology Section, West Los Angeles VA Hospital | |
| Los Angeles, California, United States, 90073 | |
| Sutter Gould Medical Foundation | |
| Modesto, California, United States, 95335 | |
| Cardiology Associates | |
| San Diego, California, United States, 92120 | |
| Regional Cardiology Assoc. | |
| Sacramento, California, United States, 95819 | |
| United States, Colorado | |
| 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 | |
| Lakeland Regional Medical | |
| Lakeland, Florida, United States, 33805 | |
| Cardiology Reasearch 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 | |
| Florida Cardiology | |
| Orlando, Florida, United States, 32803 | |
| C/O Research Office Attn: Cardiovascular Research Dept. | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Khalid Hasan Sheikh 80 Fortenberry Road | |
| Merritt Island, Florida, United States, 32952 | |
| United States, Georgia | |
| VA Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Advocate Christ Medical Center | |
| Oak Lawn, Illinois, United States, 60453 | |
| 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 | |
| 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 | |
| Cardiovascular Institute of the South | |
| Houma, Louisiana, United States, 70360 | |
| Cardiovascular Instiute of the South | |
| Morgan City, Louisiana, United States, 70380 | |
| Richard Gilmore 501 S. Ryan Street | |
| Lake Charles, Louisiana, United States, 70601 | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Androscoggin Cardiology Associates Research | |
| Auburn, Maine, United States, 04201 | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| University of Massachusett | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Thoracic & Cardiovascular Healthcare Foundation | |
| Lansing, Michigan, United States, 48910 | |
| Riverside Osteopathic Hospital | |
| Trenton, Michigan, United States, 48183 | |
| United States, Minnesota | |
| St. Paul Heart Clinic | |
| St. Paul, Minnesota, United States, 55102 | |
| VA Medical Center Therapeutic Section | |
| Minneapolis, Minnesota, United States, 55417 | |
| Regional Heart Center | |
| Duluth, Minnesota, United States, 55805 | |
| 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 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Lindner Clinical Trial Ctr. | |
| Cincinnati, Ohio, United States, 45219 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201 | |
| Hillsboro Cardiology | |
| Hillsboro, Oregon, United States, 97123 | |
| United States, Pennsylvania | |
| Cardiology Foundation of Lankenau | |
| Wynnewood, Pennsylvania, United States, 19096 | |
| 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 | |
| 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 | |
| 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 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Riverside Regional Medical Center | |
| Newport News, Virginia, United States, 23601 | |
| United States, Washington | |
| FHS Research | |
| Tacoma, Washington, United States, 98405 | |
| Daniel Gottlieb 16259 Sylvester Road SW Suite 401 | |
| Seattle, Washington, United States, 98166 | |
| United States, Wisconsin | |
| Wisconsin Center for Clinical Research | |
| Milwaukee, Wisconsin, United States, 53251 | |
| 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 | |
| Wisconsin Center for Clinical Research | |
| Elkhorn, Wisconsin, United States, 53121 | |
| Canada, Alberta | |
| Rockyview General Hospital CV Lab Research | |
| Calgary, Alberta, Canada, T2V 1P9 | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 4N1 | |
| Canada, British Columbia | |
| Cardiology Research St. Paul's Hospital | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Canada, Manitoba | |
| Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3E0Z3 | |
| Canada, Ontario | |
| Hamilton Health Sciences Crop | |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| University of Ottawa Heart Institute | |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Neureka Research Corporation | |
| Sudbury, Ontario, Canada, P3E6B4 | |
| Cardiac Investigation Unit | |
| London, Ontario, Canada, N6A 5A5 | |
| Canada, Quebec | |
| Recherche Cardiologie | |
| Montreal, Quebec, Canada, H2L4M1 | |
| Hospital Sacre-Coeur de Montreal | |
| Montreal, Quebec, Canada, H4J1C5 | |
| Quebec Heart Institute | |
| Sainte-Foy, Quebec, Canada, G1V4G5 | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T1C8 | |
| Study Director: | Preston M Dunnmon, MD | Procter and Gamble |
More Information
| Responsible Party: | Procter & Gamble Pharmaceuticals ( Preston M Dunnmon, MD ) |
| Study ID Numbers: | 2000038 |
| Study First Received: | May 3, 2002 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00035477 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 |