Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00035490

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 III

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:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators Shock

Drug Information available for: Azimilide dihydrochloride Azimilide

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 February 09, 2012