None listed
Conditions
Interventions
None listed
Sponsors
The Catholic University of Korea, Bucheon St. Mary's
Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 19~75 years as of the date of written consent 2) Hypercholesterolemia Patients who need to treat with Pitavastatin or Atorvastatin 3) Patients who meet the below cliteria -100 mg/dL = Fasting plasma glucose (FPG) = 125 mg/dL or 5.7% = HbA1c = 6.4% - Triglyceride (TG) < 400 mg/dL & Low density lipoprotein-cholesterol (LDL-C) 4) Patients who are willing to participate in the Low-Intervention Clinical Trial and signed an infromed consent document 5) Patients who are willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion criteria
Exclusion criteria: 1) Those with statin dosage within six months from the time of screening (Visit 1) 2) A person whose medical history or surgical/procedural has been verified: (1) Unstable angina occurring within 12 weeks from the time of screening; myocardial infarction, routine ischemia, cerebrovascular disease (e.g., stroke, cerebral infarction, cerebral hemorrhage, etc.) coronary bypass or coronary interventions (2) Muscle disease, rhabdomyolysis (3) Alcohol or drug abuse within one year from the time of screening (Visit 1) (4) Malicious tumors within five years from the time of screening (Visit 1) 3) The following accompanying diseases and laboratory tests are accompanied by abnormalities: (1) FPG = 126 mg/dL or HbA1c = 6.5% (2) Systolic blood pressure (SBP) = 180 which is not controlled by medication mmHg or dynamic blood pressure (DBP) = 110 mmHg) (3) Thyroid-stimulating abnormalities that are not controlled by medication hormone (TSH) = 2 X organ normal (ULN) or TSH < 0.5 X organ normal, LLN (4) Creatine kinase (CK) = 2 X ULN (5) Serum creatinine = 2 X ULN (6) Aspartate aminotransferase (AST) or Alan aminotransferase (ALT) = 3 X ULN (7) Biliary obstruction or bile lump (8) Muscle disease 4) A person who is administering cyclosporin, glycarprebir or fibrentasbir 5) Those who are expected to take/take the following medication/food during the test period, including the screening period (see 6.3.2 Prohibition and Prohibition for details) (1) Pitavastatin or Atorvastatin and other lipid modulators (2) Any other drug or food that may affect lipids in the blood; (3) Diabetes medicine (but taboo before diabetes) (4) Any drug known to have drug interactions with other Pitavastatin or Atorvastatin. 6) A person who has been given another test medication or applied a medical device within 12 weeks from the time of screening (Visit 1) 7) A person who is hypersensitive to Pitavastatin or Atorvastatin or its constituent components. 8) Patients with digestive vaginosis (cron disease, peptic ulcer, acute or chronic pancreatitis, etc.) that can affect the absorption of Pitavastatin or Atorvastatin, or who have a history of gastrointestinal surgery (except simple appendectomy or hernia surgery) 9) Patients with genetic problems such as galactose intolerance, Lap lactase deficiencies, or glucose-galactose malabsorbtion. 10) Pregnant women and men who do not agree with the pregnant or breastfeeding and the proper contraception*. * Contraception: 1.Inertation of intramuscular devices or intrauterine systems; 2.double-blocking (killers and condoms); contraceptive vaginal membrane, vaginal sponge or cervical cap, 3. Infertility procedures (jerial joint surgery, two-sided intubation, etc.) 11) Other test takers find it difficult to perform the low-medium load test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New Onset Diabetes Mellitus(%) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood sugar and insulin secretion rate, lipid profile rate, target LDL-C rate | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Rae Kim
The Catholic University of Korea, Bucheon St. Mary's Hospital
Outcome results
None listed