Status:
AVAILABLE
A Multicenter Randomized Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Diabetes
CVD
Eligibility:
All Genders
20-79 years
Brief Summary
Diabetic patients have an excess risk of mortality due to cardiovascular diseases (CVD) compared to non-diabetics. Cardiovascular disease mortality rate is reportedly on the rise in several countries ...
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) and 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) will be eligible. The main exclusion criteria will be 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 80 mg/d of SFC fenofibrate.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00965315
Last Update
December 21 2012
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