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

Completed · Phase 3 · Has a placebo group

Conditions studied: Arrhythmia

In brief

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.

Key facts

Study ID

NCT00035490

Run by

Forest Laboratories

People needed

633

Starts

2001-09-01

Expected to finish

2004-04-01

Last updated by the study team

2011-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Currently have an ICD implanted
• Have had a documented episode of symptomatic arrhythmias that triggered a spontaneous ICD shock within 180 days of randomization.
• If the ICD implant is recent, the patient must have had a documented episode of sustained arrhythmias or cardiac arrest within 42 days before implantation of the ICD

You may not qualify if…

• have severe heart failure
• have a current diagnosis of psychosis
• use illicit drugs
• abuse alcohol
• if female, are currently breast feeding, or plan to become pregnant during the study
• are currently taking antiarrhythmic drugs or other drugs that prolong the QTc interval (a measurement taken from the ECG)
• creatinine >2.5 mg/dL (221 mmol/L)
• potassium <4.0 mEq or >5.5 mEq
• have a neutrophil count (ANC) < 100 mL (low count of a type of white blood cell) at time of randomization
• have 2 or more consecutive QTc values >440 msec

Where it is running

• Tri-City Cardiology Consultants, P.C. — Mesa, Arizona, United States
• UAMS Dept of Cardiology — Little Rock, Arkansas, United States
• ATC/Cardio Medical Grp — Beverly Hills, California, United States
• Loma Linda Univ. Med. Ctr. — Loma Linda, California, United States
• Good Samaritan Hospital — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Regional Cardiology Associates — Sacramento, California, United States
• Cardiac Arrythmia Associates — San Diego, California, United States
• UCSD Medical Center — San Diego, California, United States
• Memorial Hospital — Colorado Springs, Colorado, United States
• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Florida Arrythmia Consultants — Fort Lauderdale, Florida, United States
• Southwest Florida Health Group — Fort Myers, Florida, United States
• Jacksonville Heart Center — Jacksonville, Florida, United States
• The Watson Clinic, LLP — Lakeland, Florida, United States
• Univ. Miami Jackson Mem. med. Ctr. — Miami, Florida, United States
• Florida Heart Institute — Orlando, Florida, United States
• Memorial Health Systems/Cardiology Research Associates — Ormond Beach, Florida, United States
• Loyola University Med. Ctr. — Maywood, Illinois, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Mid-America Cardiology c/o KU medical Ctr — Kansas City, Kansas, United States
• University Cardiology — Louisville, Kentucky, United States
• Louisville Cardiology Medical Group, PSC — Louisville, Kentucky, United States
• The Heart Group — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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