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NCT00035477 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
A Phase 3 study of Atrial Fibrillation, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 446
- Enrollment target
- 20
- Study locations
NCT00035477: Completed Phase 3 study of Atrial Fibrillation, sponsored by Forest Laboratories.
NCT00035477 is a Phase 3 study of Atrial Fibrillation that has completed, run by Forest Laboratories. The registered enrollment target is 446 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035477, a Phase 3 study of Atrial Fibrillation, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 446 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azimilide Dihydrochloride
Study Locations (20)
California
- Cardiovascular Associates of Penisula - Burlingame
- San Diego Cardiovascular Research Associates - Encinitas
- La Mesa Cardiac Center, a Medical Group - La Mesa
- Good Samaritan Hospital - Los Angeles
- LAC + USC Medical Center - Los Angeles
- Cardiology Section, West Los Angeles VA Hospital - Los Angeles
- Merced Heart Associates - Merced
- Sutter Gould Medical Foundation - Modesto
- ARI Clinical Trials - Redondo Beach
- Inland Clinical Research - Riverside
- Regional Cardiology Assoc. - Sacramento
- Cardiology Associates - San Diego
Florida
- Cardiology Consultants - Daytona Beach
- C/O Research Office Attn: Cardiovascular Research Dept. - Fort Lauderdale
- Jacksonville Center for Clinical Research - Jacksonville
Alabama
- The Heart Group, PC - Mobile
Arizona
- University Medical Center - Tucson
Colorado
- Western Cardiology Assoc. - Denver
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- The George Washington University MFA - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2000-09 |
| Est. Completion | 2003-10 |
| Phase | Phase 3 |
What the finished NCT00035477 record still lists
NCT00035477 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00035477 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00035477 about?
NCT00035477 is a clinical study titled "Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation". 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 o...
What is the current status of trial NCT00035477?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2000-09. Estimated completion is 2003-10.
What conditions does trial NCT00035477 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT00035477?
The interventions under investigation include: Placebo (DRUG), Azimilide Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00035477?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00035477 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00035477's enrollment target sits among peer trials
446 64th of 202 higher than 139 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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