Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
- Conditions
- Cardiovascular Diseases
- Interventions
- Registration Number
- NCT00352183
- 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 evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- Mixed dyslipidemia
- Diabetes,
- Known hypersensitivity to fenofibrate or simvastatin,
- Pregnant or lactating women,
- Contra-indication to fenofibrate or simvastatin,
- Unstable or severe cardiac disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Fenofibrate/Simvastatin - 2 Simvastatin -
- Primary Outcome Measures
Name Time Method 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 24 weeks of treatment in Triglycerides 24 weeks Percent change from baseline to 24 weeks of treatment in HDL-C 24 weeks Percent change from baseline to 24 weeks of treatment in LDL-C 24 weeks
Trial Locations
- Locations (67)
Site 508
🇱🇹Palanga, Lithuania
Site 506
🇱🇹Kaunas, Lithuania
Site 204
🇦🇺Adelaide, Australia
Site 109
🇳🇿Takapuna, Auckland, New Zealand
Site 225
🇦🇺Ingleburn, Australia
Site 207
🇦🇺Brisbane, Australia
Site 505
🇱🇹Klaipeda, Lithuania
Site 507
🇱🇹Klaipeda, Lithuania
Site 504
🇱🇹Siauliai, Lithuania
Site 103
🇳🇿Auckland, New Zealand
Site 108
🇳🇿Dunedin, New Zealand
Site 111
🇳🇿Hastings, New Zealand
Site 101
🇳🇿Christchurch, New Zealand
Site 501
🇱🇹Vilnius, Lithuania
Site 208
🇦🇺Brisbane, Australia
Site 105
🇳🇿Tauranga, New Zealand
Site 102
🇳🇿Auckland, New Zealand
Site 110
🇳🇿Newtown, Wellington, New Zealand
Site 104
🇳🇿Hamilton, New Zealand
Site 106
🇳🇿Nelson, New Zealand
Site 203
🇦🇺Bendigo, Australia
Site 212
🇦🇺Elizabeth Vale, Australia
Site 220
🇦🇺Coffs Harbour, Australia
Site 217
🇦🇺Fitzroy, Australia
Site 214
🇦🇺Adelaide, Australia
Site 218
🇦🇺Daw Park, Australia
Site 201
🇦🇺Camperdown, Australia
Site 221
🇦🇺Brisbane, Australia
Site 202
🇦🇺Burnie, Australia
Site 222
🇦🇺Fremantle, Australia
Site 216
🇦🇺Geelong, Australia
Site 213
🇦🇺Kippa-ring, Australia
Site 211
🇦🇺Meadowbrook, Australia
Site 209
🇦🇺Launceston, Australia
Site 219
🇦🇺Liverpool, Australia
Site 224
🇦🇺Miranda, Australia
Site 205
🇦🇺Parkville, Australia
Site 215
🇦🇺Sydney, Australia
Site 301
🇪🇪Tallinn, Estonia
Site 223
🇦🇺Malvern, Australia
Site 302
🇪🇪Tallinn, Estonia
Site 210
🇦🇺Nambour, Australia
Site 305
🇪🇪Tallinn, Estonia
Site 206
🇦🇺Sale, Australia
Site 306
🇪🇪Tallinn, Estonia
Site 303
🇪🇪Tallinn, Estonia
Site 603
ðŸ‡ðŸ‡ºBalatonfured, Hungary
Site 609
ðŸ‡ðŸ‡ºKecskemet, Hungary
Site 605
ðŸ‡ðŸ‡ºBudapest, Hungary
Site 608
ðŸ‡ðŸ‡ºBudapest, Hungary
Site 304
🇪🇪Tartu, Estonia
Site 307
🇪🇪Tartu, Estonia
Site 604
ðŸ‡ðŸ‡ºGyongyos, Hungary
Site 607
ðŸ‡ðŸ‡ºSopron, Hungary
Site 602
ðŸ‡ðŸ‡ºGyor, Hungary
Site 610
ðŸ‡ðŸ‡ºHodmezovasarhely, Hungary
Site 601
ðŸ‡ðŸ‡ºMiskolc, Hungary
Site 606
ðŸ‡ðŸ‡ºSzekesfehervar, Hungary
Site 406
🇱🇻Jekabpils, Latvia
Site 404
🇱🇻Tukums, Latvia
Site 403
🇱🇻Daugavpils, Latvia
Site 401
🇱🇻Ogre, Latvia
Site 405
🇱🇻Riga, Latvia
Site 503
🇱🇹Kaunas, Lithuania
Site 502
🇱🇹Alytus, Lithuania
Site 402
🇱🇻Riga, Latvia
Site 107
🇳🇿Blenheim, New Zealand