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

Phase 3

Completed

• Conditions: Arrhythmias
• Interventions: Drug: azimilide dihydrochloride

• Registration Number: NCT00751738
• Lead Sponsor: Forest Laboratories

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	azimilide dihydrochloride	125 mg azimilide

Primary Outcome Measures

Name	Time	Method
safety of azimilide in this patient population	1 year

Trial Locations

Locations (2)

Research Facility; 🇪🇸 Valencia, Spain

Research Site; 🇨🇦 Halifax, Nova Scotia, Canada