Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00035477
First received: May 3, 2002
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

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
Placebo Comparator: 1
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
Experimental: 2
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
Forest Laboratories
Investigators
Study Director: Preston M Dunnmon, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Preston M Dunnmon, MD, Procter & Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00035477     History of Changes
Other Study ID Numbers: 2000038
Study First Received: May 3, 2002
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013