Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
NCT00035464 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azimilide Dihydrochloride
Study Locations (20)
California
- Cardiovascular Associates of Penisula — Burlingame
- Capitol Interventional Cardiology — Carmichael
- VA Central California Health Care System — Fresno
- Valley Research — Fresno
- Grass Valley Cardiology — Grass Valley
- San Diego Cardiovascular Associates — La Jolla
- 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
- Regional Cardiology Assoc. — Sacramento
- Sacramento Heart and Vascular Medical Associates — Sacramento
- Cardiology Associates — San Diego
Alabama
- Cardiovascular Assoc. PC — Birmingham
- The Heart Group, PC — Mobile
Arizona
- Southern Arizona VA Health Care System, Section of Cardiology (1-111C) — Tucson
- University Medical Center — Tucson
Arkansas
- University of Arkansas Medical Center — Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 431 participants |
| Start Date | 2000-12 |
| Est. Completion | 2004-01 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00035464
The ClinicalTrials.gov registry entry for NCT00035464 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 431 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: NCT00035464 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 NCT00035464 about?
NCT00035464 is a clinical study titled "Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.". 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...
What is the current status of trial NCT00035464?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 431 participants. The study started on 2000-12. Estimated completion is 2004-01.
What conditions does trial NCT00035464 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 NCT00035464?
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 NCT00035464?
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 NCT00035464 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.