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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: Completed Phase 3 study of Arrhythmia, sponsored by Forest Laboratories.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00035490 record still lists
NCT00035490 is an interventional study that assigns participants to a tested intervention. The registered 633 participants enrollment target is mid-sized for trials with a published cap, below the 1,849-participant average among 16 other Arrhythmia trials with a reported enrollment target (66% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
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Where NCT00035490's enrollment target sits among peer trials
633 6th of 16 higher than 11 of 16 other Arrhythmia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arrhythmia 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.
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