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NCT00752596 Clinical Trial

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

Congestive Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00752596
Other study ID # 2005076
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2008
Last updated January 31, 2017
Start date September 2005
Est. completion date July 2006

Study information
Verified date January 2017
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Research Site Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary There was no outcome measure in this compassionate use
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