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The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | colesevelam HCl Tablets and simvastatin tablets |
|
| 2 | Placebo Comparator | simvastatin and Welchol placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colesevelam HCl tablets, and simvastatin tablets | Drug | colesevelam HCl tablets, 6/day simvastatin tablet, 1/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 and % change of total cholesterol | 6 Weeks | |
| The absolute 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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| simvastatin tablets and colesevelam HCl placebo | Drug | simvastatin tablet, 1/day; Welchol placebo tablets, 6/day |
|
| 6 Weeks |
| The absolute and % change in HDL-C | 6 Weeks |
| Castle Rock |
| Colorado |
| United States |
| Jacksonville | Florida | United States |
| Pembroke Pines | Florida | United States |
| St. Petersburg | Florida | United States |
| Chicago | Illinois | 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 |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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