NCT00934258

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
Last Updated

December 21, 2012

Status Verified

November 1, 2012

First QC Date

July 6, 2009

Last Update Submit

December 20, 2012

Conditions

Hyperlipidemia

Keywords

genesrosuvastatinfenofibrateCardiovascular (CV) diseasesdyslipidemiametabolic syndromeidentify genetic determinants of the wide range of interindividual variability in phenotypic and clinical response to the lipid-lowering drug classesidentify genetic susceptibility to drug-related side effects.

Interventions

rosuvastatin,fenofibrateDRUG

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

CYP2C9, UGT1A1, UGT1A3, OATP2, BCRPGENETIC

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

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 20-79 years with definite DM or atherosclerotic vascular diseases with metabolic syndrome, defined as the presence of three or more of the following risk factors:
  • abdominal obesity (waist circumference \> 90 cm in men or \> 80 cm in women),
  • triglycerides \> 150 mg/dL, HDL-cholesterol \< 40 mg/dL in men or \< 50 mg/dL in women,
  • blood pressure \> 130/85 mm Hg, or
  • fasting glucose \> 100 mg/dL).
  • Those who are qualified for lipid lowering therapy according to the Taiwanese national guidelines (LDL-C 130-190 mg/dL or TG 200-500 mg/dL with HDL-C \< 40 mg/dL or TC/HDL-C \> 5).

You may not qualify if:

  • Any known contraindications to statin or fibrate therapy,
  • Previous intolerance to statin or fibrate in low or high doses,
  • Liver enzyme levels more than 3 times the upper limit of normal,
  • Pregnancy or breastfeeding,
  • Nephrotic syndrome,
  • Uncontrolled diabetes mellitus (HbA1c \> 9),
  • Uncontrolled hypothyroidism,
  • Plasma LDL-C level higher than 190 mg/dL or triglyceride level higher than 500 mg/dL,
  • Coronary heart disease event or revascularisation within a month,
  • Congestive heart failure (New York Heart Association classification IIIb or IV),
  • Hemodynamically important valvular heart disease,
  • Gastrointestinal conditions affecting absorption of drugs,
  • Treatment with other drugs that seriously affect the pharmacokinetics of statins or fibrate,
  • Unexplained creatine phosphokinase concentrations six or more times the upper limit of normal,
  • Life-threatening malignancy,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperlipidemiasDiseaseDyslipidemiasMetabolic Syndrome

Interventions

Rosuvastatin CalciumFenofibrateCytochrome P-450 CYP2C9UDP-Glucuronosyltransferase 1A9

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPhenolsKetonesLimonene HydroxylasesCytochrome P450 Family 2Cytochrome P-450 Enzyme SystemCytochromesEnzymes and CoenzymesMixed Function OxygenasesOxygenasesOxidoreductasesEnzymesHemeproteinsProteinsAmino Acids, Peptides, and ProteinsGlucuronosyltransferaseHexosyltransferasesGlycosyltransferasesTransferases

Central Study Contacts

chau-chung Wu, Phd

CONTACT

+886-2-23123456chauchungwu@ntu.edu.tw

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 8, 2009

Last Updated

December 21, 2012

Record last verified: 2012-11