Patients with elevated LDL-C
Conditions
Interventions
Pitavastatin treatment group
Atorvastatin treatment group
Rosuvastatin treatment group
Sponsors
Fukuoka University School of Medicine Department of Cardiology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with elevated LDL-cholesterol Inclusion criteria 1)Patients with LDL-C >= 140mg/dL 2)Patients who are unable to reach LDL-C goal (JAS) 2.Patients who meet the criteria for inclusion and written informed consent to participate. 3.Outpatients(Age >= 20 years old) 4.Male or Female
Exclusion criteria
Exclusion criteria: 1.Familial hypercholesterolemia 2.Uncontrolled diabetic patients defined as HbA1c>8.0% 3.Uncontrolled thyroid disorder patients 4.Severe hepatic disorders or biliary atresia(ALT,AST >= 2 times the upper limit of normal) 5.CK(CPK)>2 times the upper limit of normal 6.Nephrotic syndrome or severe renal disorder defined as serum creatinine >=2.0 mg/dl 7.Myocardial infarction within the previous six months 8.Stroke occurred within six months 9.A history of malignant tumor within 5 years of enrollment or suspicion of present malignancy 10.Patients with a history of hypersensitivity to statins 11.Patients who have ever discontinued administration of study drugs 12.Pregnant and potential pregnancy 13.Patients judged as being inappropriate for the study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Incidence of adverse drug reactions (ADRs) 2.Change of LDL-C | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence of adverse events (AEs) 2.Incidence of abnormal laboratory test values and ADRs associated with abnormal laboratory test values 3.Number of AEs and ADRs 4.Change of laboratory test values 5.Discontinuation related ADRs 6.Incidence of abnormal laboratory test values and ADRs associated with abnormal laboratory test values related hepatic function, renal function and the musculo-skeletal system 7.Classification of ADRs related hepatic and renal function based on CTCAE v3.0 8.Classification of ADRs related to the musculo-skeletal system based on grade classification published by Ministry of Health, Labour and Welfare 9.Change of HDL-C 10.Change of triglyceride 11.Change of HDL-C/LDL-C ratio 12.Percent patients reaching the LDL-C goal 13.Change of charge modified LDL 14.Change of LDL particle number 15.Change of small dense LDL 16.Change of hs-CRP | — |
Countries
Japan
Contacts
Public ContactKeita Noda
Fukuoka University hospital Clinical research assist center
Outcome results
None listed