This is a double-blind, randomized study designed to compare the efficacy and safety of two
fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin
145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the
blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers
fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug
has been marketed in more than 80 countries since 1975. Simvastatin is also used for the
treatment of patients with a high level of cholesterol. These have also been marketed
worldwide for more than 20 years. It is important to treat high levels of fats in the blood
because it has been shown that even mildly elevated level of lipids in the blood can lead to
diseases of the blood vessels. It has been shown in several studies and in clinical practice
that the combination of fenofibrate plus simvastatin can lead to improved effects on blood
fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the
study is to compare the efficacy of the two fixed-combinations (FC) - fenofibrate/simvastatin
145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing
high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in
reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Site Reference ID/Investigator# 77956, Buenos Aires, Argentina
Site Reference ID/Investigator# 77957, Buenos Aires B1605DSX, Argentina
Site Reference ID/Investigator# 77958, Buenos Aires B1657BHD, Argentina
Site Reference ID/Investigator# 77959, Buenos Aires B1878GEG, Argentina
Site Reference ID/Investigator# 77960, Buenos Aires B1722COV, Argentina
Site Reference ID/Investigator# 77961, Buenos Aires 7600, Argentina
Site Reference ID/Investigator# 77965, Buenos Aires C1405BCH, Argentina
Site Reference ID/Investigator# 77967, Buenos Aires C1179AAB, Argentina
Site Reference ID/Investigator# 77968, Buenos Aires C1181ACK, Argentina
Site Reference ID/Investigator# 77969, Buenos Aires B2800DGH, Argentina
Site Reference ID/Investigator# 77966, Cipolletti - Rio Negro 8324, Argentina
Site Reference ID/Investigator# 77955, Santa Fe 3000, Argentina
Site Reference ID/Investigator# 77962, Santa Fe 3000, Argentina
Site Reference ID/Investigator# 77964, Santa Fe S2000DSV, Argentina
Site Reference ID/Investigator# 77963, Tucuman 4000JCU, Argentina
Site reference ID/Investigator # 99617, Benatky nad Jizerou 294 71, Czech Republic
Site reference ID/Investigator # 102335, Brno 65691, Czech Republic
Site Reference ID/Investigator# 80097, Brno 656 91, Czech Republic
Site Reference ID/Investigator# 80094, Prague 10 108 00, Czech Republic
Site Reference ID/Investigator# 80095, Prague 4 14059, Czech Republic
Site Reference ID/Investigator# 80093, Praha 8 18081, Czech Republic
Site Reference ID/Investigator# 80098, Teplice 415 01, Czech Republic
Site Reference ID/Investigator# 80096, Usti nad Labem 40113, Czech Republic
Site Reference ID/Investigator# 80099, Znojmo 669 02, Czech Republic
Site reference ID/Investigator # 97356, Berlin 10117, Germany
Site reference ID/Investigator # 97357, Berlin 13125, Germany
Site Reference ID/Investigator# 80100, Berlin 12351, Germany
Site Reference ID/Investigator# 90673, Berlin 10249, Germany
Site reference ID/Investigator # 102017, Dortmund 44137, Germany
Site reference ID/Investigator # 99876, Dresden 01069, Germany
Site Reference ID/Investigator# 80102, Dusseldorf 40597, Germany
Site Reference ID/Investigator# 80103, Essen 45359, Germany
Site Reference ID/Investigator# 80104, Essen 45355, Germany
Site Reference ID/Investigator# 80105, Frankfurt 60594, Germany
Site Reference ID/Investigator# 80101, Goch 47574, Germany
Site reference ID/Investigator # 99902, Hamburg 20253, Germany
Site reference ID/Investigator # 102015, Karlsruhe 76199, Germany
Site reference ID/Investigator # 102016, Koeln 51069, Germany
Site Reference ID/Investigator# 77970, Guadalajara, Jal. C.P. 44130, Mexico
Site Reference ID/Investigator# 77972, Mexico D.F. C.P. 11850, Mexico
Site Reference ID/Investigator# 77973, Mexico D.F. C.P. 06600, Mexico
Site Reference ID/Investigator# 77974, Zapopan 45200, Mexico
Site Reference ID/Investigator# 80111, Gdansk 80-952, Poland
Site Reference ID/Investigator# 80112, Gdansk 80-952, Poland
Site Reference ID/Investigator# 80110, Gdynia 81-423, Poland
Site Reference ID/Investigator# 80106, Katowice 40-954, Poland
Site Reference ID/Investigator# 80109, Plock 09-400, Poland
Site Reference ID/Investigator# 80108, Skierniewice 96-100, Poland
Site Reference ID/Investigator# 80107, Warsaw 01-868, Poland
Site reference ID/Investigator # 80115, Bucharest 10242, Romania
Site Reference ID/Investigator# 80113, Bucharest 42122, Romania
Site Reference ID/Investigator# 80114, Bucharest 11172, Romania
Site Reference ID/Investigator# 80116, Bucharest 20054, Romania
Site Reference ID/Investigator# 80117, Bucharest 11794, Romania
Site Reference ID/Investigator# 80119, Bucharest 22328, Romania
Site Reference ID/Investigator# 80118, Iasi 700547, Romania
Site Reference ID/Investigator# 80120, Kemerovo 650002, Russian Federation
Site Reference ID/Investigator# 80124, Moscow 119991, Russian Federation
Site Reference ID/Investigator# 80127, Moscow 125284, Russian Federation
Site Reference ID/Investigator# 80135, Moscow 119435, Russian Federation
Site Reference ID/Investigator# 80137, Moscow 119620, Russian Federation
Site Reference ID/Investigator# 80121, Novosibirsk 630047, Russian Federation
Site Reference ID/Investigator# 80122, Novosibirsk 630008, Russian Federation
Site Reference ID/Investigator# 80133, Novosibirsk 630068, Russian Federation
Site reference ID/Investigator # 80126, St. Petersburg 197022, Russian Federation
Site reference ID/Investigator # 80128, St. Petersburg 197022, Russian Federation
Site reference ID/Investigator # 80134, St. Petersburg 194156, Russian Federation
Site Reference ID/Investigator# 80136, St. Petersburg 199106, Russian Federation
Site Reference ID/Investigator# 80125, Yaroslavl 150010, Russian Federation