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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00965315 |
Purpose
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 in the region, including urban China, Malaysia, Korea and Taiwan. Cardiovascular diseases and stroke are always the number 2 and 3 killers for Taiwanese population in recent years, and they really cost much from our medical resource. For treating dyslipidemia, one of the major risk factor for CVD, statins have been well documented to reduce CV deaths both for primary and secondary prevention in several large-scale trials. It has been reported that the clinical benefits of treating dyslipidemia in patients with diabetes mellitus should be at least equivalent to the benefits observed among those with cardiovascular disease. A meta-analysis of seven trials of statins found that treatment for about 5 years resulted in a 25% reduction in the combined outcome of coronary heart disease death and non-fatal myocardial infarction. Fibrates are another group of hypolipidemic drugs that regulate lipid metabolism and are used quite often in daily practice for diabetic dyslipidemia, because of its beneficial effect to reduce high TG and increase low HDL-C, which are the characteristic lipid abnormalities commonly seen in the patients with diabetes or metabolic syndrome. However, in recently published FIELD study, fenofibrate did not significantly reduce the risk of the primary outcome of coronary events in 9,795 participants with type 2 diabetes mellitus. The higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit. Furthermore, all the treatment trials to back up the lipid treatment guideline were conducted in Caucasians and no data about the combination therapy with fibrate and statin was published before.
| Condition | Intervention |
|---|---|
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Diabetes CVD |
Drug: Rosuvastatin,SFC fenofibrate |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 20 Years to 79 Years |
| Genders Eligible for Study: | Both |
with definite DM or atherosclerotic vascular diseases with metabolic syndrome (defined as the presence of three or more of the following risk factors:
Contacts and Locations| Contact: chau chung wu, Phd | +886-2-23123456 ext 65428 | chauchungwu@ntu.edu.tw |
More Information
| Responsible Party: | Chau chung Wu / MD, NTUH |
| ClinicalTrials.gov Identifier: | NCT00965315 History of Changes |
| Other Study ID Numbers: | 200711014M |
| Study First Received: | August 24, 2009 |
| Last Updated: | August 24, 2009 |
| Health Authority: | Taiwan: Department of Health |
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CV (cardiovascular) MI (myocardial infarction) fenofibrate rosuvastatin this trial is to test the hypothesis that the addition of fenofibrate on rosuvastatin would provide a further reduction in the time |
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Atherosclerosis Diabetes Mellitus Vascular Diseases Metabolic Syndrome X Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Resistance Hyperinsulinism |
Fenofibrate Rosuvastatin Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |