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The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Welchol + TriCor |
|
| 2 | Placebo Comparator | Welchol + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colesevelam HCl tablets and fenofibrate tablets | Drug | Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| % change in LDL-C from baseline | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change in LDL-C from baseline | 6 weeks | |
| The absolute change and % change in LDL-C from week -8 (untreated) | 14 weeks | |
| The percentage of patients who achieved target LDL-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longwood | Florida | United States | ||||
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| fenofibrate tablets and Welchol placebo tablets | Drug | fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day |
|
| fenofibrate tablets and Welchol placebo tablets | Drug | fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day |
|
| 6 Weeks |
| Ocala |
| Florida |
| United States |
| Winterpark | Florida | United States |
| Chicago | Illinois | United States |
| Lombard | Illinois | United States |
| Overland Park | Kansas | United States |
| Stateville | North Carolina | United States |
| Cincinnati | Ohio | United States |
| San Antonio | Texas | United States |
| Richmond | Virginia | United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D006950 | Hyperlipidemia, Familial Combined |
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
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| ID | Term |
|---|---|
| D000069472 | Colesevelam Hydrochloride |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D000499 | Allylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D010636 | Phenols |
| D007659 | Ketones |
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