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

Tracking Information

First Received Date ^ICMJE

May 3, 2002

Last Updated Date

July 17, 2009

Start Date ^ICMJE

September 2000

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00035477 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Atrial Fibrillation

Intervention ^ICMJE

Drug: Azimilide Dihydrochloride
Drug: Placebo

Study Arms / Comparison Groups

Placebo Comparator: placebo tablets in hospital and placebo tablets outpatient
Experimental: Azimilide tablets in hospital and azimilide tablets outpatient

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

446

Completion Date

October 2003

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00035477

Responsible Party

Preston M Dunnmon, MD, Procter & Gamble Pharmaceuticals

Study ID Numbers ^ICMJE

2000038

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Preston M Dunnmon, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP