The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
830
Percent Change From Baseline Low Density Lipoprotein-cholesterol (LDL-C) at Week 12
Time frame: Baseline to 12 weeks
Percent Change From Baseline in Total Cholesterol (TC)
Percent change in total cholesterol from baseline to Week 12
Time frame: Baseline to 12 Weeks
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)
percent change from baseline in high density lipoprotein-cholesterol (HDL-C)
Time frame: Baseline to 12 weeks
TC:HDL-C Ratio
Ratio of mean total cholesterol to mean HDL-C at 12 weeks
Time frame: 12 weeks
Triglycerides (TG)
mean triglycerides at 12 weeks
Time frame: 12 weeks
Non-HDL:HDL Ratio
Ratio of non-HDL to HDL at 12 weeks
Time frame: 12 weeks
Apolipoprotein B (Apo B)
Apolipoprotein B at 12 weeks
Time frame: 12 weeks
Apolipoprotein-A1 (Apo-A1)
Apolipoprotein-A1 at 12 weeks
Time frame: 12 weeks
Apo-B:Apo-A1 Ratio
Ratio of Apo-B to Apo-A1 at 12 weeks
Time frame: 12 weeks
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Copenhagen University Hospital
Copenhagen, Denmark
Medical Center
Copenhagen, Denmark
Y Forskning, Bispebjerg Hospital
Copenhagen Nv, Denmark
Frederiks Hospital, Kardiologisk
Frederiksberg, Denmark
Kolesterollaboratoriet
Hellerup, Denmark
CCBR A/S
Vejle, Denmark
Geri-Med Oy
Helsinki, Finland
Kaisaniemen Laakariasema
Helsinki, Finland
keravan Laakarikeskus
Helsinki, Finland
SOK-tyoterveyshuolto
Tampere, Finland
...and 182 more locations
High Sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks
high sensitivity C-reactive protein (hs-CRP) at 12 weeks
Time frame: 12 weeks
Oxidized LDL at 12 Weeks
oxidized low density lipoprotein at 12 weeks
Time frame: 12 weeks
National Cholesterol Education Program [NCEP]LDL-C Target Attainment
Number of patients achieving NCEP LDL-C target (LDL-C less than or equal to 130 mg/dL)
Time frame: up to 12 weeks