Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azimilide 2HCl
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring patients, with ICD
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
1 tablet of 125 mg/day of azimilide 2HCl, oral
Outcomes
Primary Outcome Measures
There was no outcome measure in this compassionate use
Secondary Outcome Measures
Full Information
NCT ID
NCT00752596
First Posted
September 11, 2008
Last Updated
January 31, 2017
Sponsor
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT00752596
Brief Title
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
patients, with ICD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
1 tablet of 125 mg/day of azimilide 2HCl, oral
Intervention Type
Drug
Intervention Name(s)
Azimilide 2HCl
Intervention Description
One tablet of 125 mg/day azimilide 2HCl, taken until the study is terminated
Primary Outcome Measure Information:
Title
There was no outcome measure in this compassionate use
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen R Marcello, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
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