Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease
NCT00137332
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- Patients with or without ICDs (implantable cardioverter defibrillators)
- Patients undergoing an electrophysiology study for evaluation of ventricular rhythm
- Patients with a history of heart disease
- Patients with uncontrolled blood pressure
- Patients with certain cardiac risk factors
- Patients with significant kidney or liver problems
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease | |||
Official Title ICMJE | A Study of the Effects GAP-486 on Ventricular Tachyarrhythmia Induction | |||
Brief Summary | The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Arrhythmia | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | 90 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | October 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00137332 | |||
Other Study ID Numbers ICMJE | 3163K1-202 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |