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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00035490

Enrollment

633

Registered

2002-05-06

Start date

2001-09-30

Completion date

2004-04-30

Last updated

2011-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia

Brief 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.

Interventions

DRUGAzimilide Dihydrochloride

125 mg azimilide, once a day for one year

DRUGplacebo

placebo tablet, once daily for one year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reducing the recurrence of all-cause shocks plus symptomatic ATP	one year

Countries

Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026