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This study will investigate the effects of the combination of fluvastatin and fenofibrate on dyslipidemia in comparison to the combination of simvastatin and ezetimibe.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluvastatin extended release, fenofibrate | Drug | |||
| Fixed combination simvastatin/ezetimibe | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| High density lipoprotein cholesterol (HDL-C) measured at the end of each study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Compared at the end of each treatment period: | ||
| patients reaching target levels of low density lipoprotein cholesterol (LDL-C) <100mg/dl | ||
| patients reaching target levels of non-HDL-C <130mg/ |
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Inclusion Criteria:
Written informed consent to participate in the study prior to any study procedures.
Male or female subjects, age between 18-75 years inclusive.
All women of child bearing potential must have a negative pregnancy test
Metabolic Syndrome according to the International Diabetes Federation definition:
Low plasma HDL-C (Men < 40 mg/dl ; Women < 50 mg/dl ).
Elevated waist circumference (men ≥ 94 cm, women ≥ 80cm)
And one or more of the following criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Centers | Germany | |||||
| Novartis Pharma AG |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| LDL-C/HDL-C |
| Triglycerides |
| LDL subfractions in a subgroup of patients |
| Basel |
| Switzerland |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |