Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000519-21 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 atorvastatin monotherapy in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate / simvastatin | Drug | Combination of fenofibrate and simvastatin 20 mg and 40 mg |
| |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 501 | Haskovo | Bulgaria | ||||
| Site 505 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Atorvastatin |
| Drug |
Atorvastatin 10 mg and 20mg |
|
| 24 weeks |
| Pleven |
| Bulgaria |
| Site 503 | Plovdiv | Bulgaria |
| Site 506 | Plovdiv | Bulgaria |
| Site 500 | Sofia | Bulgaria |
| Site 502 | Sofia | Bulgaria |
| Site 504 | Sofia | Bulgaria |
| Site 507 | Sofia | Bulgaria |
| Site 509 | Sofia | Bulgaria |
| Site 511 | Sofia | Bulgaria |
| Site 508 | Varna | Bulgaria |
| Site 510 | Varna | Bulgaria |
| Site 109 | Chrudim | Czechia |
| Site 117 | Havířov | Czechia |
| Site 101 | Olomouc | Czechia |
| Site 114 | Olomouc | Czechia |
| Site 116 | Ostrava | Czechia |
| Site 107 | Pardubice | Czechia |
| Site 111 | Pardubice | Czechia |
| Site 113 | Pilsen | Czechia |
| Site 100 | Prague | Czechia |
| Site 104 | Prague | Czechia |
| Site 108 | Prague | Czechia |
| Site 110 | Prague | Czechia |
| Site 115 | Prague | Czechia |
| Site 103 | Teplice | Czechia |
| Site 106 | Trutnov | Czechia |
| Site 118 | Uničov | Czechia |
| Site 102 | Ústí nad Orlicí | Czechia |
| Site 203 | Berlin | Germany |
| Site 204 | Bochum | Germany |
| Site 205 | Dresden | Germany |
| Site 206 | Görlitz | Germany |
| Site 202 | Hamburg | Germany |
| Site 208 | Karlsruhe | Germany |
| Site 207 | Leipzig | Germany |
| Site 201 | Magdeburg | Germany |
| Site 209 | Nuremberg | Germany |
| Site 200 | Unterschneidheim | Germany |
| Site 301 | Banská Bystrica | Slovakia |
| Site 307 | Bratislava | Slovakia |
| Site 310 | Bratislava | Slovakia |
| Site 311 | Bratislava | Slovakia |
| Site 312 | Bratislava | Slovakia |
| Site 309 | Dolný Kubín | Slovakia |
| Site 302 | Košice | Slovakia |
| Site 305 | Lučenec | Slovakia |
| Site 306 | Nitra | Slovakia |
| Site 304 | Nové Zámky | Slovakia |
| Site 308 | Prešov | Slovakia |
| Site 303 | Vráble | Slovakia |
| Site 300 | Žilina | Slovakia |
| Site 416 | Donetsk | Ukraine |
| Site 401 | Kharkiv | Ukraine |
| Site 412 | Kiev | Ukraine |
| Site 402 | Kyiv | Ukraine |
| Site 404 | Kyiv | Ukraine |
| Site 408 | Kyiv | Ukraine |
| Site 410 | Kyiv | Ukraine |
| Site 414 | Lutsk | Ukraine |
| Site 406 | Lviv | Ukraine |
| Site 407 | Odesa | Ukraine |
| Site 409 | Odesa | Ukraine |
| Site 411 | Odesa | Ukraine |
| Site 405 | Simferopol | Ukraine |
| Site 413 | Uzhhorod | Ukraine |
| Site 400 | Vinnitsa | Ukraine |
| Site 415 | Zaporizhzhya | Ukraine |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided