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| Sponsored by: |
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 |
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Atrial Fibrillation |
Drug: Azimilide Dihydrochloride Drug: Placebo |
Phase III |
| Genetics Home Reference related topics: | Brugada syndrome familial atrial fibrillation short QT syndrome |
| MedlinePlus related topics: | Arrhythmia |
| Drug Information available for: | Azimilide dihydrochloride Azimilide |
| 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 |
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1: Placebo Comparator
Placebo tablets
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Drug: Placebo
placebo tablets, twice a day for 6 months
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2: Experimental
125 mg azimilide tablets
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Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months
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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![]() |
Show 103 Study Locations |
| Procter and Gamble |
| Study Director: | Martin Phillips, MD | Procter and Gamble |
More Information
| Responsible Party: | Procter & Gamble Pharmaceuticals ( Martin Phillips, MD ) |
| Study ID Numbers: | 2000037 |
| First Received: | May 3, 2002 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00035464 |
| Health Authority: | United States: Food and Drug Administration |
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