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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751738

Enrollment

330

Registered

2008-09-12

Start date

2002-10-31

Completion date

2005-10-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias

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.

Interventions

DRUGazimilide dihydrochloride

oral, once daily until sponsor stopped the study

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
safety of azimilide in this patient population	1 year

Countries

Belgium, Canada, France, Germany, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026