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Sponsored by: |
Procter and Gamble |
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Information provided by: | Procter and Gamble |
ClinicalTrials.gov Identifier: | NCT00751738 |
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
Condition | Intervention | Phase |
---|---|---|
Arrhythmias |
Drug: azimilide dihydrochloride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label, Follow-up Study to Assess the Long-Term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator |
Enrollment: | 330 |
Study Start Date: | October 2002 |
Study Completion Date: | October 2005 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
125 mg azimilide
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Drug: azimilide dihydrochloride
oral, once daily until sponsor stopped the study
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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:
Study Director: | Jose M Brum, MD | Procter and Gamble |
Responsible Party: | Procter and Gamble Pharmaceuticals ( Jose Brum, MD ) |
Study ID Numbers: | 2001060 |
Study First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751738 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Calcium, Dietary Heart Diseases Calcium Channel Blockers Cardiovascular Agents |
Anti-Arrhythmia Agents Azimilide Arrhythmias, Cardiac |
Membrane Transport Modulators Pathologic Processes Heart Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions Azimilide Arrhythmias, Cardiac |