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NCT00035464 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
A Phase 3 study of Atrial Fibrillation, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 431
- Enrollment target
- 20
- Study locations
NCT00035464: Completed Phase 3 study of Atrial Fibrillation, sponsored by Forest Laboratories.
NCT00035464 is a Phase 3 study of Atrial Fibrillation that has completed, run by Forest Laboratories. The registered enrollment target is 431 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00035464, a Phase 3 study of Atrial Fibrillation, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 431 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT00035464 record still lists
NCT00035464 is an interventional study that assigns participants to a tested intervention. The registered 431 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 (86% 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.
NCT00035464 names 20 study sites across 4 states, led by California, Alabama, Arizona.
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.
What interventions are being tested in trial NCT00035464?
The interventions under investigation include: Placebo (DRUG), Azimilide Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00035464?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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
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 NCT00035464's enrollment target sits among peer trials
431 67th of 202 higher than 136 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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