Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient

This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.

Completed

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Scottsdale, Arizona, 85251, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

No inclusion criteria as the patient to be included is this compassionate use protocol is currently receiving azimilide therapy

Exclusion criteria

Currently taking Class I or other Class III antiarrhythmic drug or other drugs that may prolong QT interval.
Is unwilling or unable to give or understand informed consent.

Treatment and study plan

Azimilide 2HCl

Drug

One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated

Primary outcomes

There was no outcome measure in this compassionate use

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

Compassionate Use Study to Assess the Long Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in One Patient Following Termination of the SHIELD Open-label Study 2001060

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 15, 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