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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
575
Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
Site Reference ID/Investigator# 77961
Buenos Aires, Argentina
Site Reference ID/Investigator# 77957
Buenos Aires, Argentina
Site Reference ID/Investigator# 77958
Buenos Aires, Argentina
Site Reference ID/Investigator# 77960
Buenos Aires, Argentina
Site Reference ID/Investigator# 77959
Buenos Aires, Argentina
Percentage of Change of TG (Triglyceride)
Collection and measurement of blood samples.
Time frame: from baseline to 12 weeks of treatment
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
Collection and measurement of blood samples.
Time frame: from baseline to 12 weeks of treatment
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
Collection and measurement of blood samples.
Time frame: from baseline to 12 weeks of treatment
Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
Collection and measurement of blood samples
Time frame: 12 weeks
Percentage of TC (Triglyceride) From Baseline
Collection and measurement of blood samples
Time frame: 12 weeks
Percentage of Apolipoprotein AI From Baseline
Collection and measurement of blood samples
Time frame: 12 weeks
Percentage of Apolipoprotein B From Baseline
Collection and measurement of blood samples
Time frame: 12 weeks
Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
Collection and measurement of blood samples
Time frame: 12 weeks
Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
Collection and measurement of blood samples
Time frame: 12 weeks
Adverse Events
Collection and measurement of blood samples
Time frame: 12 weeks
Creatine Kinase (CK)
Collection and measurement of blood samples
Time frame: 12 weeks
Alanine Aminotransferase (ALT)
Collection and measurement of blood samples
Time frame: 12 weeks
Plasma Creatinine
Collection and measurement of blood samples
Time frame: 12 weeks
Total Bilirubin
Collection and measurement of blood samples
Time frame: 12 weeks
Cystatin C
Collection and measurement of blood samples
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 77969
Buenos Aires, Argentina
Site Reference ID/Investigator# 77967
Buenos Aires, Argentina
Site Reference ID/Investigator# 77968
Buenos Aires, Argentina
Site Reference ID/Investigator# 77965
Buenos Aires, Argentina
Site Reference ID/Investigator# 77956
Buenos Aires, Argentina
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