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NCT00035490 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
A Phase 3 study of Arrhythmia, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 633
- Enrollment target
- 20
- Study locations
NCT00035490 is a Phase 3 study of Arrhythmia that has completed, run by Forest Laboratories. The registered enrollment target is 633 participants, below the 1,849-participant average among 16 other Arrhythmia trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00035490, a Phase 3 study of Arrhythmia, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 633 participants
- Enrollment target
- 20
- Study locations
Study Summary
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks. The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.
Conditions Studied
Interventions
- DRUG placebo
- DRUG Azimilide Dihydrochloride
Study Locations (20)
California
- ATC/Cardio Medical Grp - Beverly Hills
- Loma Linda Univ. Med. Ctr. - Loma Linda
- Good Samaritan Hospital - Los Angeles
- VA Greater Los Angeles Healthcare System - Los Angeles
- Regional Cardiology Associates - Sacramento
- Cardiac Arrythmia Associates - San Diego
- UCSD Medical Center - San Diego
Florida
- Florida Arrythmia Consultants - Fort Lauderdale
- Southwest Florida Health Group - Fort Myers
- Jacksonville Heart Center - Jacksonville
- The Watson Clinic, LLP - Lakeland
- Univ. Miami Jackson Mem. med. Ctr. - Miami
- Florida Heart Institute - Orlando
- Memorial Health Systems/Cardiology Research Associates - Ormond Beach
Alabama
- The Heart Group - Mobile
Arizona
- Tri-City Cardiology Consultants, P.C. - Mesa
Arkansas
- UAMS Dept of Cardiology - Little Rock
Colorado
- Memorial Hospital - Colorado Springs
Connecticut
- Bridgeport Hospital - Bridgeport
District of Columbia
- Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 633 participants |
| Start Date | 2001-09 |
| Est. Completion | 2004-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00035490
The ClinicalTrials.gov registry entry for NCT00035490 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 633 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,849-participant average among 16 other Arrhythmia trials with a reported enrollment target (66% lower). The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arrhythmia appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00035490 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00035490 about?
NCT00035490 is a clinical study titled "Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators". Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude ...
What is the current status of trial NCT00035490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 633 participants. The study started on 2001-09. Estimated completion is 2004-04.
What conditions does trial NCT00035490 study?
This clinical trial studies the following conditions: Arrhythmia.
What interventions are being tested in trial NCT00035490?
The interventions under investigation include: placebo (DRUG), Azimilide Dihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00035490?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00035490 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.