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The objective of this study is to evaluate the effects of adding Tricor 145 mg to once daily atorvastatin 20 mg on CHD lipid laboratory parameters.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate | Drug | |||
| ezetimibe | Drug | |||
| atorvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from Combination Baseline to 12 weeks post-Combination Baseline in direct measured HDL-C and TG. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Advanced lipid and inflammatory parameters | Week 12 |
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Inclusion Criteria:
Subject is >= 18 years of age, any race, and any gender.
Subjects must have the following fasting parameters:
Subjects must have one or more of the following:
Subject has, in the opinion of the investigator, a life expectancy greater than 6 months.
Female subjects must have a negative pregnancy test prior to study enrollment.
Female subjects of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study.
Subject must be willing to observe the Step I Diet recommended by the NCEP throughout the study.
Subject must be willing to participate in the study and to complete all follow-up assessments.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information | Abbott | Study Director |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |