Skip to main content
OpenTrials
Completed

NCT Number: NCT00035490

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

A.Z. Sint-Jan, Ruddershove, 10, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azimilide Dihydrochloride

Drug

125 mg azimilide, once a day for one year

Placebo

Drug

placebo tablet, once daily for one year

Primary outcomes

  1. Reducing the recurrence of all-cause shocks plus symptomatic ATP

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
May 6, 2002
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.