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Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia

NCT00934258 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2012-12-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

rosuvastatin,fenofibrate

Rosuvastatin 10 mg once daily Rosuvastatin 5 mg + SFC fenofibrate 80 mg

GENETIC

CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP

All potential patients will be screened for the eligibility in a screening visit. Those who fill the inclusion criteria at screening will be invited for the registry study into different groups. The follow-up will take place at months 6, 12, 18, and every year thereafter for another 3 years, through clinical visiting, phone follow-up, or records from the NHIB Taiwan. At each clinical visit, vital signs, clinical endpoints, adverse events, concurrent medication information and laboratory specimens will be obtained as complete as possible. With phone or records from NHIB, only clinical endpoints will be recorded. If the primary care physician intends to treat the patient's lipid profile to the target, he/she can add, delete or adjust the LLT by his/her clinical judgement

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934258 on ClinicalTrials.gov