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To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Experimental | JTT-705 300mg |
|
| 3 | Experimental | JTT-705 600mg |
|
| 4 | Experimental | JTT-705 900mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo tablet, 3 tablets, oral, once daily after breakfast |
| |
| 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 ratio | 4-weeks |
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Inclusion Criteria:
Patients with of Type II hyperlipidaemia
Patients having lipid values as indicated below:
Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen | Amsterdam | Netherlands |
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| 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 |
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| ID | Term |
|---|---|
| C411602 | dalcetrapib |
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| JTT-705 300mg |
| Drug |
JTT-705 tablet, 1 tablet, oral, once daily, after breakfast. Placebo tablet, 2 tablets, oral, once daily, after breakfast. |
|
| JTT-705 600mg | Drug | JTT-705 tablet, 2 tablets, oral, once daily, after breakfast. Placebo tablet, 1 tablet, oral, once daily, after breakfast |
|
| JTT-705 900mg | Drug | JTT-705 tablet, 3 tablets, oral, once daily, after breakfast |
|
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |