Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation - Full Text View

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00035477

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Azimilide Dihydrochloride Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Azimilide dihydrochloride Azimilide

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment:	446
Study Start Date:	September 2000
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator placebo tablets in hospital and placebo tablets outpatient	Drug: Placebo placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient
2: Experimental Azimilide tablets in hospital and azimilide tablets outpatient	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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035477

Show 82 Study Locations

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Preston M Dunnmon, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter & Gamble Pharmaceuticals ( Preston M Dunnmon, MD )
Study ID Numbers:	2000038
Study First Received:	May 3, 2002
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00035477 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heart Diseases
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Azimilide
Membrane Transport Modulators

Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009