Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 446 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (85% lower). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
-
The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
RECRUITING · Phase 3
-
Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR
RECRUITING · Phase 3
-
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
RECRUITING · Phase 3
-
Semaglutide for Metabolic Intervention and Adipose Loss to Treat Atrial Fibrillation
RECRUITING · Phase 3
-
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)
RECRUITING · Phase 3
-
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.