Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Condition(s) targeted: Hyperlipidemia

Intervention: Fenofibrate/Simvastatin (Drug); Fenofibrate/Simvastatin (Drug); Pravastatin (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 pravastatin 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 40 mg Pravastatin Monotherapy in Patients With Mixed Dyslipidemia at Risk of Cardiovascular Disease Not Adequately Controlled by 40 mg Pravastatin 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 to 12 weeks of treatment 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 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 pravastatin

- Pregnant or lactating women

- Contra-indication to fenofibrate or simvastatin or pravastatin

- Unstable or severe cardiac disease

Site 39, Ioannina, Greece

Site 40, Athens, Greece

Site 41, Thessaloniki, Greece

Site 17, Ramat Gan, Israel

Site 18, Jerusalem, Israel

Site 19, Haifa, Israel

Site 20, Rechovot, Israel

Site 21, Ramat Gan, Israel

Site 22, Holon, Israel

Site 23, Tel-Aviv, Israel

Site 24, Safed, Israel

Site 37, Beer Yaakov, Israel

Site 38, Kfar Saba, Israel

Site 1, Bucuresti, Romania

Site 2, Targu Mures, Romania

Site 3, Ploiesti, Romania

Site 4, Oradea, Romania

Site 5, Arad, Romania

Site 6, Cluj-Napoca, Romania

Site 7, Bacau, Romania

Site 25, Moscow, Russian Federation

Site 26, Smolensk, Russian Federation

Site 27, Barnaul, Russian Federation

Site 28, Novosibirsk, Russian Federation

Site 29, St. Petersburg, Russian Federation

Site 30, Voronezh, Russian Federation

Site 31, Kemerovo, Russian Federation

Site 32, Krasnoyarsk, Russian Federation

Site 8, Pretoria, South Africa

Site 9, Bloemfontein, South Africa

Site 10, Alberton, South Africa

Site 11, Parow, South Africa

Site 12, Port Elizabeth, South Africa

Site 13, Krugersdorp, South Africa

Site 14, Cape Town, South Africa

Site 15, Worcester, South Africa

Site 16, Komatipoort, South Africa

Site 33, Hillcrest, South Africa

Site 34, Kempton Park, South Africa

Site 35, Durban, South Africa

Site 36, Umkomaas, South Africa

Starting date: September 2006
Ending date: August 2008
Last updated: February 21, 2008