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| Tracking Information | |||||
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| First Received Date ICMJE | March 21, 2008 | ||||
| Last Updated Date | December 1, 2009 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00644592 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | LXRA Gene Polymorphisms and Response to Fenofibrate | ||||
| Official Title ICMJE | LXRA Gene Polymorphisms and Response to Fenofibrate | ||||
| Brief Summary | This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Placebo Control Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00644592 | ||||
| Responsible Party | Issam Zineh, PharmD, University of Florida College of Pharmacy, Department of Pharmacy Practice, Center for Pharmacogenomics | ||||
| Study ID Numbers ICMJE | 302-2007 | ||||
| Study Sponsor ICMJE | University of Florida | ||||
| Collaborators ICMJE | American College of Clinical Pharmacy | ||||
| Investigators ICMJE |
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| Information Provided By | University of Florida | ||||
| Verification Date | December 2009 | ||||
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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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