Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

NCT00035490 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 633 participants
Start Date 2001-09
Est. Completion 2004-04
Phase Phase 3

Sponsor

Forest Laboratories

32 total trials

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 NCT00035490

The ClinicalTrials.gov registry entry for NCT00035490 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 633 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 Arrhythmia 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: NCT00035490 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00035490?

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 NCT00035490?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial