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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00035490
First received: May 3, 2002
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Arrhythmia
 Drug: Azimilide Dihydrochloride
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Reducing the recurrence of all-cause shocks plus symptomatic ATP [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 633
Study Start Date: September 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo tablets
 Drug: placebo
placebo tablet, once daily for one year
Experimental: 2
75 mg azimilide
 Drug: Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
Experimental: 3
125 mg azimilide
 Drug: Azimilide Dihydrochloride
125 mg azimilide, once a day for one year

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035490

  Show 142 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Jose M Brum, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Jose Brum, MD, Procter & Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00035490     History of Changes
Other Study ID Numbers: 2000098
Study First Received: May 3, 2002
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Azimilide
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013