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

This study has been completed.
Sponsor:
Information provided by:
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00751738
First received: September 11, 2008
Last updated: March 22, 2010
Last verified: March 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

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
Experimental: 1
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
Warner Chilcott
Investigators
Study Director: Jose M Brum, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Jose Brum, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00751738     History of Changes
Other Study ID Numbers: 2001060
Study First Received: September 11, 2008
Last Updated: March 22, 2010
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 June 18, 2013