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

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ClinicalTrials.gov Identifier: NCT00751738
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : February 1, 2017
Sponsor:
Information provided by:
Forest Laboratories

Brief Summary:
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 or disease Intervention/treatment Phase
Arrhythmias Drug: azimilide dihydrochloride Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
125 mg azimilide
Drug: azimilide dihydrochloride
oral, once daily until sponsor stopped the study




Primary Outcome Measures :
  1. safety of azimilide in this patient population [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751738


  Show 86 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Jose M Brum, MD Procter and Gamble

Responsible Party: Jose Brum, MD, Procter and Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00751738     History of Changes
Other Study ID Numbers: 2001060
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Azimilide
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action