Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia

Status Available

Clinical Trial Summary

Previous studies indicate that the variant status of detoxification proteins is different among Taiwanese and other ethnic groups. For example, in Taiwanese, the major SNPs of CYP2C9 are CYP2C9*2 (430C>T) and CYP2C9*3 (1075A>C) and their frequencies are different from that in Caucasians [11]. The second example is that the frequency of the A(TA)7TAA allele in the promoter area of the UGT1A1 gene is substantially lower, while for the rate of variation within the coding region is much higher in Taiwanese than that in Caucasians (14.3% vs. 35.7- 41.5% and 29.3% vs. 0.1%, respectively) [12]. The third example is that the frequency of 388A>G of the OATP2 gene in Taiwanese (0.68) [13] is in between that in European Americans (0.30) and African Americans (0.74) [14]. Therefore, the investigators hypothesize that, in Taiwanese the SNPs of detoxification proteins modulate the lipid-lowing effects of RVA and fenofibrate may be different from those for Caucasians.

Clinical Trial Description

Since April 2008, we have started to run a multicenter, prospective, randomized, open-label, blinded end-point classification trial to test the hypothesis in Taiwan that the addition of fibrate on statin would provide a further reduction in the major coronary events in the patients with diabetes or atherosclerotic vascular diseases with metabolic syndrome. With the advantage of this large-scaled prospective trial, it is also a good opportunity to identify simultaneously the genetic determinants of wide range of interindividual variability in phenotypic and clinical response to two major lipid-lowering drug classes, rosuvastatin and fenofibrate. The aim of this proposal is to find which SNPs influence the therapeutic effectiveness of lipid lowering therapy in Taiwanese hyperlipidemic patients. A key feature is the use of multiple drug-treated population samples to get the findings derived from both candidate gene and genome-wide searches for SNP associations with markers of drug efficacy as well as side effects. Thus the promise of pharmacogenomics and metabolomics-- "individualized medicine" will come true in treating hyperlipidemia in Taiwanese. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00934258
Study type	Expanded Access
Source	National Taiwan University Hospital
Contact	chau-chung Wu, Phd
Phone	+886-2-23123456
Email	chauchungwu@ntu.edu.tw
Status	Available
Phase	N/A

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.