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Determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on pravastatin therapy for at least 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | pravastatin tablets and Welchol tablets |
|
| 2 | Placebo Comparator | pravastatin tablets and Welchol placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pravastatin tablets and Welchol tablets | Drug | pravastatin tablets, 1 tablet/day for 6 weeks; Welchol Tablets, 6 tablets/day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy parameter was 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 of total cholesterol from baseline to endpoint | 6 Weeks | |
| The absolute change and % change of triglycerides from baseline to endpoint |
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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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| pravastatin tablets and Welchol placebo tablets | Drug | pravastatin tablets, 1 tablet/day; Welchol placebo tablets, 6 tablets/day |
|
| 6 Weeks |
| The absolute change and % change of HDL-C from baseline to endpoint | 6 Weeks |
| The absolute change and % change of c-reactive protein from baseline to endpoint | 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 |
| Louisville | Kentucky | 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 |
|---|---|
| D017035 | Pravastatin |
| D000069472 | Colesevelam Hydrochloride |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000499 | Allylamine |
| D000588 | Amines |
| D000498 | Allyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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