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The purpose of this study is to evaluate the effect of two dose levels of JTT-705 when co-administered with pravastatin 40 mg on HDL-C and LDL-C and the inhibition rate of CETP activity and to document short term safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | JTT-705 600 mg and pravastatin 40 mg |
|
| 2 | Experimental | JTT-705 300 mg and pravastatin 40 mg |
|
| 3 | Placebo Comparator | Placebo and pravastatin 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTT-705 600 mg and pravastatin 40 mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| % change from baseline in HDL-C; inhibition of CETP activity | 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| % change from baseline in LDL-C and TC/HDL-C | 4-weeks | |
| Plasma concentration of JTT-705 | 4-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | Amsterdam | Netherlands |
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| JTT-705 300 mg and pravastatin 40 mg | Drug |
|
|
| Placebo and pravastatin 40 mg | Drug |
|
|
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C411602 | dalcetrapib |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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