Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

This study has been completed.

First Received: September 11, 2008 No Changes Posted

Sponsored by:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00751738

Purpose

This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

Condition	Intervention	Phase
Arrhythmias	Drug: azimilide dihydrochloride	Phase III

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators

Drug Information available for: Azimilide dihydrochloride Azimilide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Open-Label, Follow-up Study to Assess the Long-Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

safety of azimilide in this patient population [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	330
Study Start Date:	October 2002
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 125 mg azimilide	Drug: azimilide dihydrochloride oral, once daily until sponsor stopped the study

Eligibility

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

Criteria

Inclusion Criteria:

patients who completed at least 12 months on study 2000098 before inclusion in this study

Exclusion Criteria:

breast feeding or plan to become pregnant
used ticlopidine
were taking Class I or other Class III drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751738

Show 86 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Jose M Brum, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Jose Brum, MD )
Study ID Numbers:	2001060
Study First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751738 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Calcium, Dietary
Heart Diseases
Calcium Channel Blockers
Cardiovascular Agents

Anti-Arrhythmia Agents
Azimilide
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Membrane Transport Modulators
Pathologic Processes
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Pharmacologic Actions
Azimilide
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009