Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00035477
• Other study ID #: 2000038
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2002
• Last updated: September 30, 2011
• Start date: September 2000
• Est. completion date: October 2003

Study information

• Verified date: September 2011
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms).

This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label follow-up phase to the study. This follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening

• Require the procedure of cardioversion (electric shock to correct heart rhythm)

• In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion.

• Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines.

Exclusion criteria:

• Previously unsuccessful electrical cardioversions

• Failed to respond to any Class III antiarrhythmic drugs

• Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Azimilide Dihydrochloride
125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient
• Placebo
placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient

Locations

Country	Name	City	State
Canada	Rockyview General Hospital CV Lab Research	Calgary	Alberta
Canada	University of Calgary	Calgary	Alberta
Canada	Hamilton Health Sciences Crop	Hamilton	Ontario
Canada	Cardiac Investigation Unit	London	Ontario
Canada	Hospital Sacre-Coeur de Montreal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Recherche Cardiologie	Montreal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Quebec Heart Institute	Sainte-Foy	Quebec
Canada	Neureka Research Corporation	Sudbury	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Cardiology Research St. Paul's Hospital	Vancouver	British Columbia
Canada	Health Sciences Centre	Winnipeg	Manitoba
United States	Heart Care Group PC	Allentown	Pennsylvania
United States	Androscoggin Cardiology Associates Research	Auburn	Maine
United States	Tri-State Medical Group Cardiology	Beaver	Pennsylvania
United States	Beloit Clinic, SC	Beloit	Wisconsin
United States	Cardiovascular Associates of Penisula	Burlingame	California
United States	Charleston Cardiology	Charleston	South Carolina
United States	Lindner Clinical Trial Ctr.	Cincinnati	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Cardiology Consultants	Daytona Beach	Florida
United States	VA Medical Center	Decatur	Georgia
United States	Western Cardiology Assoc.	Denver	Colorado
United States	Regional Heart Center	Duluth	Minnesota
United States	Duke Medical Center	Durham	North Carolina
United States	Elgin Cardiology Associates	Elgin	Illinois
United States	Wisconsin Center for Clinical Research	Elkhorn	Wisconsin
United States	San Diego Cardiovascular Research Associates	Encinitas	California
United States	C/O Research Office Attn: Cardiovascular Research Dept.	Fort Lauderdale	Florida
United States	Heart Center Medical Group	Ft. Wayne	Indiana
United States	Altru Health System Research Center	Grand Forks	North Dakota
United States	Hartford Hospital	Hartford	Connecticut
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hillsboro Cardiology	Hillsboro	Oregon
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Methodist Hospital	Houston	Texas
United States	The Care Group	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Dean/Riverview Clinic	Janesville	Wisconsin
United States	The Pavillion	Jenkintown	Pennsylvania
United States	La Mesa Cardiac Center, a Medical Group	La Mesa	California
United States	Richard Gilmore 501 S. Ryan Street	Lake Charles	Louisiana
United States	Lakeland Regional Medical	Lakeland	Florida
United States	Thoracic & Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	Cardiology Section, West Los Angeles VA Hospital	Los Angeles	California
United States	Good Samaritan Hospital	Los Angeles	California
United States	LAC + USC Medical Center	Los Angeles	California
United States	Louisville Cardiology Medical Group, P.S.C.	Louisville	Kentucky
United States	University of Louisville-Cardiology	Louisville	Kentucky
United States	University of Wisconsin Madison	Madison	Wisconsin
United States	Stern Cardiovascular Center Research Department	Memphis	Tennessee
United States	Merced Heart Associates	Merced	California
United States	Khalid Hasan Sheikh 80 Fortenberry Road	Merritt Island	Florida
United States	Wisconsin Center for Clinical Research	Milwaukee	Wisconsin
United States	VA Medical Center Therapeutic Section	Minneapolis	Minnesota
United States	The Heart Group, PC	Mobile	Alabama
United States	Sutter Gould Medical Foundation	Modesto	California
United States	Cardiovascular Instiute of the South	Morgan City	Louisiana
United States	Tulane University	New Orleans	Louisiana
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Florida Cardiology	Orlando	Florida
United States	Cardiology Reasearch Assiocates	Ormond Beach	Florida
United States	UPHS/Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Cardiovascular and Critical Care Associates, P.C.	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health Sciences University	Portland	Oregon
United States	ARI Clinical Trials	Redondo Beach	California
United States	Inland Clinical Research	Riverside	California
United States	Regional Cardiology Assoc.	Sacramento	California
United States	Heart and Vascular Inst. of Texas, PA	San Antonio	Texas
United States	Cardiology Associates	San Diego	California
United States	Daniel Gottlieb 16259 Sylvester Road SW Suite 401	Seattle	Washington
United States	St. Paul Heart Clinic	St. Paul	Minnesota
United States	FHS Research	Tacoma	Washington
United States	Riverside Osteopathic Hospital	Trenton	Michigan
United States	University Medical Center	Tucson	Arizona
United States	The George Washington University MFA	Washington	District of Columbia
United States	University of Massachusett	Worcester	Massachusetts
United States	Cardiology Foundation of Lankenau	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc		six months	No