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

Forest Laboratories

Status and phase: Completed; Phase 2

Conditions: Congestive Heart Failure

Treatments: Drug: Azimilide 2HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752596

2005076

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Male

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1 participants in 1 patient group

1

Experimental group

Description:

1 tablet of 125 mg/day of azimilide 2HCl, oral

Treatment:

Drug: Azimilide 2HCl