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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00035464 |
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Date of registration:
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03/05/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients With Atrial Fibrillation.
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Scientific title:
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Efficacy and Safety of Azimilide in the Prophylactic Treatment of Patients |
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Date of first enrolment:
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December 2000 |
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Target sample size:
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431 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00035464 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Martin Phillips, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Procter and Gamble |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Drug: Placebo
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Drug: Azimilide Dihydrochloride
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Primary Outcome(s)
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To prolong the tachycardia-free period in patients
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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