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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arrhythmias Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Facility, Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azimilide Dihydrochloride

Drug

oral, once daily until sponsor stopped the study

Primary outcomes

safety of azimilide in this patient population

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2005
Study completion: 2005
First posted: Sep 12, 2008
Registry last updated: Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed