Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin
- Conditions
- Hyperlipidemia
- Interventions
- Registration Number
- NCT00362934
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- Mixed dyslipidemia.
- Known hypersensitivity to fenofibrates or simvastatin or atorvastatin
- Pregnant or lactating women
- Contra-indication to fenofibrate or simvastatin or atorvastatin
- Unstable or severe cardiac disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 fenofibrate / simvastatin - 2 Atorvastatin -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 24 weeks
Trial Locations
- Locations (68)
Site 412
🇺🇦Kiev, Ukraine
Site 415
🇺🇦Zaporozhye, Ukraine
Site 500
🇧🇬Sofia, Bulgaria
Site 504
🇧🇬Sofia, Bulgaria
Site 507
🇧🇬Sofia, Bulgaria
Site 305
🇸🇰Lucenec, Slovakia
Site 309
🇸🇰Dolny kubin, Slovakia
Site 304
🇸🇰Nove Zamky, Slovakia
Site 303
🇸🇰Vrable, Slovakia
Site 300
🇸🇰Zilina, Slovakia
Site 408
🇺🇦Kyiv, Ukraine
Site 409
🇺🇦Odessa, Ukraine
Site 308
🇸🇰Presov, Slovakia
Site 302
🇸🇰Kosice, Slovakia
Site 402
🇺🇦Kyiv, Ukraine
Site 410
🇺🇦Kyiv, Ukraine
Site 414
🇺🇦Lutsk, Ukraine
Site 406
🇺🇦Lviv, Ukraine
Site 405
🇺🇦Simferopol, Ukraine
Site 306
🇸🇰Nitra, Slovakia
Site 505
🇧🇬Pleven, Bulgaria
Site 501
🇧🇬Haskovo, Bulgaria
Site 509
🇧🇬Sofia, Bulgaria
Site 506
🇧🇬Plovdiv, Bulgaria
Site 503
🇧🇬Plovdiv, Bulgaria
Site 502
🇧🇬Sofia, Bulgaria
Site 511
🇧🇬Sofia, Bulgaria
Site 510
🇧🇬Varna, Bulgaria
Site 109
🇨🇿Chrudim, Czech Republic
Site 101
🇨🇿Olomouc, Czech Republic
Site 508
🇧🇬Varna, Bulgaria
Site 117
🇨🇿Havirov, Czech Republic
Site 114
🇨🇿Olomouc, Czech Republic
Site 116
🇨🇿Ostrava, Czech Republic
Site 107
🇨🇿Pardubice, Czech Republic
Site 111
🇨🇿Pardubice, Czech Republic
Site 104
🇨🇿Praha 5, Czech Republic
Site 100
🇨🇿Praha 2, Czech Republic
Site 108
🇨🇿Praha 1, Czech Republic
Site 115
🇨🇿Praha, Czech Republic
Site 113
🇨🇿Plzen, Czech Republic
Site 103
🇨🇿Teplice, Czech Republic
Site 106
🇨🇿Trutnov, Czech Republic
Site 118
🇨🇿Unicov, Czech Republic
Site 204
🇩🇪Bochum, Germany
Site 102
🇨🇿Usti nad Orlici, Czech Republic
Site 209
🇩🇪Nuernberg, Germany
Site 205
🇩🇪Dresden, Germany
Site 202
🇩🇪Hamburg, Germany
Site 203
🇩🇪Berlin, Germany
Site 206
🇩🇪Gorlitz, Germany
Site 200
🇩🇪Unterschneidheim, Germany
Site 201
🇩🇪Magdeburg, Germany
Site 208
🇩🇪Karlsruhe, Germany
Site 301
🇸🇰Banska Bystrica, Slovakia
Site 207
🇩🇪Leipzig, Germany
Site 311
🇸🇰Bratislava, Slovakia
Site 307
🇸🇰Bratislava, Slovakia
Site 312
🇸🇰Bratislava, Slovakia
Site 310
🇸🇰Bratislava, Slovakia
Site 404
🇺🇦Kyiv, Ukraine
Site 407
🇺🇦Odessa, Ukraine
Site 400
🇺🇦Vinnitsa, Ukraine
Site 401
🇺🇦Kharkov, Ukraine
Site 411
🇺🇦Odessa, Ukraine
Site 416
🇺🇦Donetsk, Ukraine
Site 110
🇨🇿Praha 6, Czech Republic
Site 413
🇺🇦Uzhorod, Ukraine