Conditions: Dyslipidemia
Keywords: Fibrates Dyslipidemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 575
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Fixed Combination of Fenofibrate/simvastatin 145/20 mg intervention 2: Simvastatin 20 mg intervention 3: Fenofibrate 145 mg intervention 4: Fixed Combination of Fenofibrate/simvastatin 145/40 mg intervention 5: Simvastatin 40 mg
Intervention descriptions: intervention 1: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks intervention 2: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks intervention 3: Fenofibrate, tablet, 145 mg, once daily, 12 weeks intervention 4: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks intervention 5: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Protocol document: