This is an open-label extension study of NK-104-306 (NCT00257686) for elderly patients with hypercholesterolemia or combined dyslipidemia.
This was an open-label study of 60 weeks duration in elderly patients (≥65 years) with primary hypercholesterolemia or combined dyslipidemia who completed the 12 week treatment in study NK-104-306 and who met the inclusion/exclusion criteria. Patients who qualified started open-label treatment with pitavastatin 2 mg QD. The dose of pitavastatin could be increased to 4 mg QD after at least 8 weeks of treatment at 2 mg QD, in patients who failed to attain their LDL-C target.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
545
Change From Baseline in LDL-C
percent change from baseline in low density lipoprotein-cholesterol (LDL-C)
Time frame: Baseline to 60 weeks
Change From Baseline in Total Cholesterol
Percent change from baseline in total cholesterol (TC)
Time frame: Baseline to 60 weeks
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Copenhagen University Hospital
Copenhagen, Denmark
Medical Center
Copenhagen, Denmark
CCBR A/S
Vejle, Denmark
Kardiologische Gemeinschaftspraxis Prof. Reifart
Bad Soden/Taunus, Germany
Praxis Dr. Boenninghoff
Beckum, Germany
Klinische Forschung Berlin Mitte
Berlin, Germany
GWT-TUK GmbH, Zentrum fur Klinische Studien
Dresden, Germany
Gemeinschaftspraxis Dr. Krause, Th. Menke
Goch, Germany
Klinische Forschung Hamburg
Hamburg, Germany
Innere Medizin I/Medizinische Klinik
Heidelberg, Germany
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