Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia
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ClinicalTrials.gov Identifier: NCT00934258 |
Recruitment Status
:
Available
First Posted
: July 8, 2009
Last Update Posted
: December 21, 2012
|
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Condition or disease | Intervention/treatment |
---|---|
Hyperlipidemia | Drug: rosuvastatin,fenofibrate Genetic: CYP2C9, UGT1A1, UGT1A3, OATP2, BCRP |
Study Type : | Expanded Access |
Official Title: | Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia |

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Drug: rosuvastatin,fenofibrate

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Ages Eligible for Study: | 20 Years to 79 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
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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).
Exclusion Criteria:
- 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,
- Treatment with immuno suppressive or other lipid lowering drugs.
- Patients previously treated with monotherapy with statins or fibrates will be qualified if they have not already had titration to a dose higher than the equivalent of 5 mg/d of rosuvastatin or 160 mg/d of SFC fenofibrate.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934258
Contact: chau-chung Wu, Phd | +886-2-23123456 ext 65428 | chauchungwu@ntu.edu.tw |
Responsible Party: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00934258 History of Changes |
Other Study ID Numbers: |
200812111R |
First Posted: | July 8, 2009 Key Record Dates |
Last Update Posted: | December 21, 2012 |
Last Verified: | November 2012 |
Keywords provided by National Taiwan University Hospital:
genes rosuvastatin fenofibrate Cardiovascular (CV) diseases |
dyslipidemia metabolic syndrome identify genetic determinants of the wide range of interindividual variability in phenotypic and clinical response to the lipid-lowering drug classes identify genetic susceptibility to drug-related side effects. |
Additional relevant MeSH terms:
Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin Calcium Fenofibrate |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |