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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00752596

Enrollment

Registered

2008-09-15

Start date

2005-09-30

Completion date

2006-07-31

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

Congestive Heart Failure

Keywords

patients, with ICD

Brief summary

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.

Interventions

DRUGAzimilide 2HCl

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
There was no outcome measure in this compassionate use	—

Countries

United States

Outcome results

None listed

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