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

Phase 2

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Azimilide 2HCl

• Registration Number: NCT00752596
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Azimilide 2HCl	1 tablet of 125 mg/day of azimilide 2HCl, oral

Primary Outcome Measures

Name	Time	Method
There was no outcome measure in this compassionate use

Trial Locations

Locations (1)

Research Site; 🇺🇸 Scottsdale, Arizona, United States