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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00035451 |
Atrial fibrillation (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.
The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug, in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to correct 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 first study. The follow-up phase will continue to evaluate the long-term safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Azimilide Dihydrochloride Drug: Placebo Drug: Sotalol |
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 Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation. |
Enrollment: | 658 |
Study Start Date: | February 2001 |
Study Completion Date: | June 2003 |
Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
placebo tablets
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Drug: Placebo
tablets, twice daily for 6 months
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2: Active Comparator
Sotalol
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Drug: Sotalol
160 mg sot twice daily for 6 months
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3: Experimental
azimilide
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Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | Paloma Cuenca, MD | Procter and Gamble |
Responsible Party: | Procter & Gamble Pharmaceuticals ( Paloma Cuenca, MD ) |
Study ID Numbers: | 1999105 |
Study First Received: | May 3, 2002 |
Last Updated: | July 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00035451 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Neurotransmitter Agents Heart Diseases Adrenergic Agents Calcium Channel Blockers Cardiovascular Agents Azimilide Sotalol |
Calcium, Dietary Adrenergic beta-Antagonists Adrenergic Antagonists Atrial Fibrillation Anti-Arrhythmia Agents Peripheral Nervous System Agents Arrhythmias, Cardiac |
Sympatholytics Neurotransmitter Agents Heart Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Sotalol Azimilide |
Membrane Transport Modulators Pathologic Processes Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents Atrial Fibrillation Arrhythmias, Cardiac |