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Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation
NCT00035477 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00035477
The ClinicalTrials.gov registry entry for NCT00035477 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 446 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00035477 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00035477?
The interventions under investigation include: Placebo (DRUG), Azimilide Dihydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00035477?
This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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