Status:
AVAILABLE
Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Hyperlipidemia
Eligibility:
All Genders
20-79 years
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 (43...
Detailed 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 sta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00934258
Last Update
December 21 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.