Comparison of the Combination of Fenofibrate and Simvastatin Versus Atorvastatin

Condition(s) targeted: Hyperlipidemia

Intervention: fenofibrate / simvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Official title: A Multicenter, Double-Blind, Randomized, Forced-Titration Study to Compare the Efficacy and Safety of the Combination of 145 mg Fenofibrate and 20 or 40 mg Simvastatin With Atorvastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 10 mg Atorvastatin Alone

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change from baseline in TG, HDL-C and LDL-C

Secondary outcome: Percent change from baseline in TG, HDL-C, LDL-C, non HDL-C, TC, Apo AI and Apo B; change from baseline in hs CRP and fibrinogen. Percentage of patients reaching the NCEP ATP III target LDL-C and TG levels.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Mixed dyslipidemia.

Exclusion Criteria:

- 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

Site 500, Sofia, Bulgaria

Site 501, Haskovo, Bulgaria

Site 502, Sofia, Bulgaria

Site 503, Plovdiv, Bulgaria

Site 504, Sofia, Bulgaria

Site 505, Pleven, Bulgaria

Site 506, Plovdiv, Bulgaria

Site 507, Sofia, Bulgaria

Site 508, Varna, Bulgaria

Site 509, Sofia, Bulgaria

Site 510, Varna, Bulgaria

Site 511, Sofia, Bulgaria

Site 100, Praha 2, Czech Republic

Site 101, Olomouc, Czech Republic

Site 102, Usti nad Orlici, Czech Republic

Site 103, Teplice, Czech Republic

Site 104, Praha 5, Czech Republic

Site 106, Trutnov, Czech Republic

Site 107, Pardubice, Czech Republic

Site 108, Praha 1, Czech Republic

Site 109, Chrudim, Czech Republic

Site 110, Praha 6, Czech Republic

Site 111, Pardubice, Czech Republic

Site 113, Plzen, Czech Republic

Site 114, Olomouc, Czech Republic

Site 115, Praha, Czech Republic

Site 116, Ostrava, Czech Republic

Site 117, Havirov, Czech Republic

Site 118, Unicov, Czech Republic

Site 200, Unterschneidheim, Germany

Site 201, Magdeburg, Germany

Site 202, Hamburg, Germany

Site 203, Berlin, Germany

Site 204, Bochum, Germany

Site 205, Dresden, Germany

Site 206, Gorlitz, Germany

Site 207, Leipzig, Germany

Site 208, Karlsruhe, Germany

Site 209, Nuernberg, Germany

Site 300, Zilina, Slovakia

Site 301, Banska Bystrica, Slovakia

Site 302, Kosice, Slovakia

Site 303, Vrable, Slovakia

Site 304, Nove Zamky, Slovakia

Site 305, Lucenec, Slovakia

Site 306, Nitra, Slovakia

Site 307, Bratislava, Slovakia

Site 308, Presov, Slovakia

Site 309, Dolny kubin, Slovakia

Site 310, Bratislava, Slovakia

Site 311, Bratislava, Slovakia

Site 312, Bratislava, Slovakia

Site 400, Vinnitsa, Ukraine

Site 401, Kharkov, Ukraine

Site 402, Kyiv, Ukraine

Site 404, Kyiv, Ukraine

Site 405, Simferopol, Ukraine

Site 406, Lviv, Ukraine

Site 407, Odessa, Ukraine

Site 408, Kyiv, Ukraine

Site 409, Odessa, Ukraine

Site 410, Kyiv, Ukraine

Site 411, Odessa, Ukraine

Site 412, Kiev, Ukraine

Site 413, Uzhorod, Ukraine

Site 414, Lutsk, Ukraine

Site 415, Zaporozhye, Ukraine

Site 416, Donetsk, Ukraine

Starting date: October 2006
Ending date: August 2008
Last updated: January 25, 2008