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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00035464
First received: May 3, 2002
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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 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 in the Prophylactic Treatment of Patients

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

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

Enrollment: 431
Study Start Date: December 2000
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035464

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

No publications provided

Responsible Party: Martin Phillips, MD, Procter & Gamble Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00035464     History of Changes
Other Study ID Numbers: 2000037
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Azimilide
Anti-Arrhythmia Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014