Efficacy and Safety of Azimilide in the Prophylactic 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

December 2000

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To prolong the tachycardia-free period in patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00035464 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 in the Prophylactic Treatment of Patients With Atrial Fibrillation.

Official Title ^ICMJE

Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients

Brief Summary

Atrial fibrillation (an abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (a type of 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 prolonging the time to the first symptomatic arrhythmia recurrence in patients with a history of atrial fibrillation and congestive heart failure and/or ischemic heart disease) and those without these conditions. 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. The follow-up phase of the study is designed 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
Experimental: 125 mg azimilide tablets

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

431

Completion Date

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

History of symptomatic atrial fibrillation that significantly disrupts the patient's customary daily living activities
History of congestive heart failure and/or ischemic heart disease
Sinus rhythm (normal heart rhythm) upon entry to the 30 day screening period for the study
At least one episode of symptomatic atrial fibrillation during the screening period, with a spontaneous return to sinus rhythm.
Sinus rhythm immediately prior to dosing

Exclusion criteria:

Previously unsuccessful cardioversions within 60 days of screening period
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
Previously in an azimilide study

Gender

Both

Ages

18 Years and older

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

NCT00035464

Responsible Party

Martin Phillips, MD, Procter & Gamble Pharmaceuticals

Study ID Numbers ^ICMJE

2000037

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Martin Phillips, 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