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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Azimilide
Anti-Arrhythmia Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014