Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 29, 2007 | ||||
| Last Updated Date | December 10, 2010 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00509574 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy | ||||
| Official Title ICMJE | Association of Genetic Polymorphisms With Lipid Lowering Effects of Statin Therapy | ||||
| Brief Summary | The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. However, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation. |
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| Detailed Description | Hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. The patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. Genomic DNA was collected from the blood sample of each patient using genomic DNA purification kit. The single nucleotide polymorphisms (SNPs) were determined afterward. The correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and SNPs examined. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: blood samples are obtained for genomic DNA extraction. |
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| Sampling Method | Probability Sample | ||||
| Study Population | Hyperlipidemic patients meeting the criteria of NCEP ATPIII for drug treatment at internal medicine clinic of National Taiwan University Hospital. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Estimated Completion Date | February 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00509574 | ||||
| Other Study ID Numbers ICMJE | 200702006M | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tzung-Dau Wang, MD, PhD, National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | November 2010 | ||||
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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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