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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 22, 2005 | ||||||||
| Last Updated Date | July 26, 2006 | ||||||||
| Start Date ICMJE | January 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
ICD shock for any cause | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00257959 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Optimal Pharmacological Therapy In Implantable Defibrillator Patients (OPTIC) | ||||||||
| Official Title ICMJE | |||||||||
| Brief Summary | This is an open parallel design randomized trial of amiodarone plus a beta blocker vs a beta blocker alone vs sotalol for the prevention of ICD shocks in patients receiving an ICD for spontaneous or inducible ventricular tachycardia or fibrillation |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Ventricular Tachycardia | ||||||||
| Intervention ICMJE | Drug: amiodarone beta blocker sotalol | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 400 | ||||||||
| Completion Date | October 2004 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: spontaneous or inducible ventricular tachycardia or fibrillation - Exclusion Criteria: - |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00257959 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 1 | ||||||||
| Study Sponsor ICMJE | Connolly, Stuart, M.D. | ||||||||
| Collaborators ICMJE | St. Jude Medical | ||||||||
| Investigators ICMJE |
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| Information Provided By | Connolly, Stuart, M.D. | ||||||||
| Verification Date | November 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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