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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000515-15 |
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Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia.The overall objective of the study is to compare the efficacy and safety of combining fenofibrate and simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate/Simvastatin | Drug | Combination of Fenofibrate and Simvastatin 20mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 12 weeks of treatment in Triglycerides | 12 weeks | |
| Percent change from baseline to 12 weeks of treatment in HDL-C | 12 weeks | |
| Percent change from baseline to 12 weeks of treatment in LDL-C | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline to 12 weeks of treatment in Triglycerides | 24 weeks | |
| Percent change from baseline to 12 weeks of treatment in HDL-C | 24 weeks | |
| Percent change from baseline to 12 weeks of treatment in LDL-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 40 | Athens | Greece | ||||
| Site 39 |
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| Fenofibrate/Simvastatin |
| Drug |
Combination of Fenofibrate and Simvastatin 40 mg |
|
| Pravastatin | Drug | Pravastatin 40 mg |
|
| 24 weeks |
| Ioannina |
| Greece |
| Site 41 | Thessaloniki | Greece |
| Site 37 | Beer Yaakov | Israel |
| Site 19 | Haifa | Israel |
| Site 22 | Holon | Israel |
| Site 18 | Jerusalem | Israel |
| Site 38 | Kfar Saba | Israel |
| Site 17 | Ramat Gan | Israel |
| Site 21 | Ramat Gan | Israel |
| Site 20 | Rehovot | Israel |
| Site 24 | Safed | Israel |
| Site 23 | Tel Aviv | Israel |
| Site 5 | Arad | Romania |
| Site 7 | Bacau | Romania |
| Site 1 | Bucharest | Romania |
| Site 6 | Cluj-Napoca | Romania |
| Site 4 | Oradea | Romania |
| Site 3 | Ploieşti | Romania |
| Site 2 | Târgu Mureş | Romania |
| Site 27 | Barnaul | Russia |
| Site 31 | Kemerovo | Russia |
| Site 32 | Krasnoyarsk | Russia |
| Site 25 | Moscow | Russia |
| Site 28 | Novosibirsk | Russia |
| Site 29 | Saint Petersburg | Russia |
| Site 26 | Smolensk | Russia |
| Site 30 | Voronezh | Russia |
| Site 10 | Alberton | South Africa |
| Site 9 | Bloemfontein | South Africa |
| Site 14 | Cape Town | South Africa |
| Site 35 | Durban | South Africa |
| Site 36 | eMkhomazi | South Africa |
| Site 33 | Hillcrest | South Africa |
| Site 34 | Kempton Park | South Africa |
| Site 16 | Komatipoort | South Africa |
| Site 13 | Krugersdorp | South Africa |
| Site 11 | Parow | South Africa |
| Site 12 | Port Elizabeth | South Africa |
| Site 8 | Pretoria | South Africa |
| Site 15 | Worcester | South Africa |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D019821 | Simvastatin |
| D017035 | Pravastatin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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