The aim of this study is to demonstrate whether, along with dietary recommendations, Armolipid Plus ® can improve the profile of patients with elevated plasma LDL-C acting as a change of lifestyle therapy (TLC) according to the definition of Adult Treatment Panel III (ATP III)
Recently reported that the combination of extract of red yeast rice policosanol composed, berberine, folic acid and coenzyme Q10 (Armolipid Plus ®, Rottapharm) produced a significant improvement in lipid profile in patients with moderately elevated cholesterol levels of low density lipoprotein (LDL-C) plasma. Taking into account the potential effect of Armolipid Plus ® on the lipid profile, it is important to investigate the effectiveness in the field of cardiovascular prevention to define its position in prevention programs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
one tablet per day during 12 weeks
one tablet per day during 12 weeks
Hosp. Universitario San Joan
Reus, Tarragona, Spain
investigate whether the addition of Armolipid Plus ® decreases by 20% LDL-C levels compared to baseline in patients with initial levels of LDL-C ≥ 130 mg / dL.
Time frame: twelve weeks
Cardiovascular risk (according to the Framingham tables).
Time frame: twelve weeks
Criteria for Metabolic Syndrome
Time frame: twelve weeks
Levels of triglycerides and cholesterol high density lipoprotein (HDL-C).
Time frame: twelve weeks
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