Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00035464
Recruitment Status : Completed
First Posted : May 6, 2002
Last Update Posted : October 3, 2011
Information provided by:
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Azimilide Dihydrochloride Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients
Study Start Date : December 2000
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo tablets
Drug: Placebo
placebo tablets, twice a day for 6 months
Experimental: 2
125 mg azimilide tablets
Drug: Azimilide Dihydrochloride
125 mg azimilide tablets, twice a day for 6 months

Primary Outcome Measures :
  1. To prolong the tachycardia-free period in patients [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00035464

  Show 103 Study Locations
Sponsors and Collaborators
Forest Laboratories
Study Director: Martin Phillips, MD Procter and Gamble

Responsible Party: Martin Phillips, MD, Procter & Gamble Pharmaceuticals Identifier: NCT00035464     History of Changes
Other Study ID Numbers: 2000037
First Posted: May 6, 2002    Key Record Dates
Last Update Posted: October 3, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action