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To determine the effects of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on atorvastatin therapy for at least 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | colesevelam tablets and atorvastatin tablets |
|
| 2 | Placebo Comparator | colesevelam HCl placebo tablets and atorvastatin tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colesevelam HCl tablets, and atorvastatin tablets | Drug | colesevelam HCl tablets,6 tablets/day; atorvastatin tablets, 1 tablets/day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy parameter is the percent change in LDL-C from baseline to endpoint. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change in LDL-C from baseline to endpoint | 6 weeks | |
| The absolute change and % change in total cholesterol | 6 Weeks | |
| The absolute change and % change in triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| colesevelam HCl placebo tablets and atorvastatin tablets | Drug | colesevelam HCl placebo tablets, 6 tablets/day for 6 weeks atorvastatin tablets, 1 tablet/day for 6 weeks |
|
| 6 Weeks |
| The absolute change and % change in HDL-C | 6 Weeks |
| The absolute change and % change in C-reactive protein | 6 weeks |
| Castle Rock |
| Colorado |
| United States |
| Jacksonville | Florida | United States |
| Pembroke Pines | Florida | United States |
| St. Petersburg | Florida | United States |
| Indianapolis | Indiana | United States |
| Rochester | New York | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Bartlett | Tennessee | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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