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| Sponsor: | Forest Laboratories |
|---|---|
| Information provided by (Responsible Party): | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00035451 |
Purpose
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 |
|---|---|---|
|
Atrial Fibrillation |
Drug: Azimilide Dihydrochloride Drug: Placebo Drug: Sotalol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Placebo Comparator: 1
placebo tablets
|
Drug: Placebo
tablets, twice daily for 6 months
|
|
Active Comparator: 2
Sotalol
|
Drug: Sotalol
160 mg sot twice daily for 6 months
|
|
Experimental: 3
azimilide
|
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
|
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
Show 129 Study Locations| Study Director: | Paloma Cuenca, MD | Procter and Gamble |
More Information
| Responsible Party: | Forest Laboratories |
| ClinicalTrials.gov Identifier: | NCT00035451 History of Changes |
| Other Study ID Numbers: | 1999105 |
| Study First Received: | May 3, 2002 |
| Last Updated: | September 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Azimilide Sotalol Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators |