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Sponsored by: |
Procter and Gamble |
Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00035490 |
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.
The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.
Condition | Intervention | Phase |
Arrhythmia |
Drug: Azimilide Dihydrochloride Drug: placebo |
Phase III |
Genetics Home Reference related topics: | Brugada syndrome short QT syndrome |
MedlinePlus related topics: | Arrhythmia Pacemakers and Implantable Defibrillators |
Drug Information available for: | Azimilide dihydrochloride Azimilide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators |
Enrollment: | 633 |
Study Start Date: | September 2001 |
Study Completion Date: | April 2004 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator
Placebo tablets
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Drug: placebo
placebo tablet, once daily for one year
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2: Experimental
75 mg azimilide
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Drug: Azimilide Dihydrochloride
75 mg azimilide, once a day for one year
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3: Experimental
125 mg azimilide
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Drug: Azimilide Dihydrochloride
125 mg azimilide, once a day for one year
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Show 142 Study Locations |
Procter and Gamble |
Study Director: | Jose M Brum, MD | Procter and Gamble |
Responsible Party: | Procter & Gamble Pharmaceuticals ( Jose Brum, MD ) |
Study ID Numbers: | 2000098 |
First Received: | May 3, 2002 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00035490 |
Health Authority: | United States: Food and Drug Administration |
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