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The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in LDL-C at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks | ||
| Percent change from baseline in serum lipids at 2, 4 and 8 weeks | ||
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Warner, MD | Clinical Consultant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research | Mobile | Alabama | 36608 | United States | ||
| Radiant Research |
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| San Diego |
| California |
| 92123 |
| United States |
| Radiant Research | Daytona Beach | Florida | 32114 | United States |
| Radiant Research | Gainesville | Florida | 32605 | United States |
| Radiant Research | Boise | Idaho | 83704 | United States |
| Radiant Research | Chicago | Illinois | 60610 | United States |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | United States |
| PRA International Pharmacology Center | Lenexa | Kansas | 66219 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Radiant Research | Portland | Oregon | 97201 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Radiant Research | Austin | Texas | 78758 | United States |
| Research Across America | Dallas | Texas | 75234 | United States |
| Radiant Research | Dallas | Texas | 75235 | 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 |
|---|---|
| C445524 | FM-VP4 compound |
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