Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

Phase 3

Completed

• Conditions: Arrhythmia
• Interventions: Drug: placebo; Drug: Azimilide Dihydrochloride

• Registration Number: NCT00035490
• Lead Sponsor: Forest Laboratories

Brief Summary

Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.

The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-05-03
• Study First Submitted QC: 2002-05-03
• Study First Posted: 2002-05-06
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-30
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 633

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	Placebo tablets
2	Azimilide Dihydrochloride	75 mg azimilide
3	Azimilide Dihydrochloride	125 mg azimilide

Primary Outcome Measures

Name	Time	Method
Reducing the recurrence of all-cause shocks plus symptomatic ATP	one year

Trial Locations

Locations (142)

The Heart Group; 🇺🇸 Mobile, Alabama, United States

Tri-City Cardiology Consultants, P.C.; 🇺🇸 Mesa, Arizona, United States

UAMS Dept of Cardiology; 🇺🇸 Little Rock, Arkansas, United States

ATC/Cardio Medical Grp; 🇺🇸 Beverly Hills, California, United States

Loma Linda Univ. Med. Ctr.; 🇺🇸 Loma Linda, California, United States

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States

Regional Cardiology Associates; 🇺🇸 Sacramento, California, United States

Cardiac Arrythmia Associates; 🇺🇸 San Diego, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Scroll for more (132 remaining)