Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)

Forest Laboratories

Status and phase: Completed; Phase 3

Conditions: Arrhythmias

Treatments: Drug: azimilide dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751738

2001060

Details and patient eligibility

About

This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who completed at least 12 months on study 2000098 before inclusion in this study

Exclusion criteria

• breast feeding or plan to become pregnant
• used ticlopidine
• were taking Class I or other Class III drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

1

Experimental group

Description:

125 mg azimilide

Treatment:

Drug: azimilide dihydrochloride