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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

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring patients, with ICD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

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

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

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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