Cardiovascular Diseases Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 40 mg Simvastatin With 40 mg Simvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Simvastatin Alone.
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.
Status | Completed |
Enrollment | 450 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Mixed dyslipidemia Exclusion Criteria: - Diabetes, - Known hypersensitivity to fenofibrate or simvastatin, - Pregnant or lactating women, - Contra-indication to fenofibrate or simvastatin, - Unstable or severe cardiac disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Site 204 | Adelaide | |
Australia | Site 214 | Adelaide | |
Australia | Site 203 | Bendigo | |
Australia | Site 207 | Brisbane | |
Australia | Site 208 | Brisbane | |
Australia | Site 221 | Brisbane | |
Australia | Site 202 | Burnie | |
Australia | Site 201 | Camperdown | |
Australia | Site 220 | Coffs Harbour | |
Australia | Site 218 | Daw Park | |
Australia | Site 212 | Elizabeth Vale | |
Australia | Site 217 | Fitzroy | |
Australia | Site 222 | Fremantle | |
Australia | Site 216 | Geelong | |
Australia | Site 225 | Ingleburn | |
Australia | Site 213 | Kippa-ring | |
Australia | Site 209 | Launceston | |
Australia | Site 219 | Liverpool | |
Australia | Site 223 | Malvern | |
Australia | Site 211 | Meadowbrook | |
Australia | Site 224 | Miranda | |
Australia | Site 210 | Nambour | |
Australia | Site 205 | Parkville | |
Australia | Site 206 | Sale | |
Australia | Site 215 | Sydney | |
Estonia | Site 301 | Tallinn | |
Estonia | Site 302 | Tallinn | |
Estonia | Site 303 | Tallinn | |
Estonia | Site 305 | Tallinn | |
Estonia | Site 306 | Tallinn | |
Estonia | Site 304 | Tartu | |
Estonia | Site 307 | Tartu | |
Hungary | Site 603 | Balatonfured | |
Hungary | Site 605 | Budapest | |
Hungary | Site 608 | Budapest | |
Hungary | Site 604 | Gyongyos | |
Hungary | Site 602 | Gyor | |
Hungary | Site 610 | Hodmezovasarhely | |
Hungary | Site 609 | Kecskemet | |
Hungary | Site 601 | Miskolc | |
Hungary | Site 607 | Sopron | |
Hungary | Site 606 | Szekesfehervar | |
Latvia | Site 403 | Daugavpils | |
Latvia | Site 406 | Jekabpils | |
Latvia | Site 401 | Ogre | |
Latvia | Site 402 | Riga | |
Latvia | Site 405 | Riga | |
Latvia | Site 404 | Tukums | |
Lithuania | Site 502 | Alytus | |
Lithuania | Site 503 | Kaunas | |
Lithuania | Site 506 | Kaunas | |
Lithuania | Site 505 | Klaipeda | |
Lithuania | Site 507 | Klaipeda | |
Lithuania | Site 508 | Palanga | |
Lithuania | Site 504 | Siauliai | |
Lithuania | Site 501 | Vilnius | |
New Zealand | Site 102 | Auckland | |
New Zealand | Site 103 | Auckland | |
New Zealand | Site 107 | Blenheim | |
New Zealand | Site 101 | Christchurch | |
New Zealand | Site 108 | Dunedin | |
New Zealand | Site 104 | Hamilton | |
New Zealand | Site 111 | Hastings | |
New Zealand | Site 106 | Nelson | |
New Zealand | Site 110 | Newtown, Wellington | |
New Zealand | Site 109 | Takapuna, Auckland | |
New Zealand | Site 105 | Tauranga |
Lead Sponsor | Collaborator |
---|---|
Solvay Pharmaceuticals |
Australia, Estonia, Hungary, Latvia, Lithuania, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Triglycerides | 12 weeks | No | |
Primary | Percent change from baseline to 12 weeks of treatment in HDL-C | 12 weeks | No | |
Primary | Percent change from baseline to 12 weeks of treatment in LDL-C | 12 weeks | No | |
Secondary | Percent change from baseline to 24 weeks of treatment in Triglycerides | 24 weeks | No | |
Secondary | Percent change from baseline to 24 weeks of treatment in HDL-C | 24 weeks | No | |
Secondary | Percent change from baseline to 24 weeks of treatment in LDL-C | 24 weeks | No |
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