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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arrhythmia

Intervention / Treatment
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* Drug: Azimilide Dihydrochloride
* Drug: placebo
* Drug: Azimilide Dihydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablets | Drug: placebo<br>* placebo tablet, once daily for one year<br>|
| Experimental: 2<br>75 mg azimilide | Drug: Azimilide Dihydrochloride<br>* 75 mg azimilide, once a day for one year<br>|
| Experimental: 3<br>125 mg azimilide | Drug: Azimilide Dihydrochloride<br>* 125 mg azimilide, once a day for one year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the recurrence of all-cause shocks plus symptomatic ATP |  | one year |