hypercholesterolemia
Conditions
Interventions
Rosuvastatin 5 mg (1 tablet of rosuvastatin 5 mg tablet or 2 tablets of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 8 weeks.
Atorvastatin 10mg (1 tablet of atorvastatin 10 m
Sponsors
Graduate School of Medicine, the University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are not received statins, fibrates, cholesterol absorption inhibitors, or probucol therapy within past 2 months 2) Patients who do not reach JAS guideline 2007 LDL-C goal* (* It is available to use the latest value measured under a fasting condition within 2 months of consent agreement. If no measured values are available, values calculated by Friedewald's formula [LDL- C = TC - HDL - C - TG/5] may be used.) 3) Patients who are able to submit written consent agreement by themselves
Exclusion criteria
Exclusion criteria: 1) Patients with severe hypertension (SBP >= 180mmHg or DBP >= 110mmHg) 2) Patients with type I diabetes 3) Patients with familial hypercholesterolemia 4) Patients with fasting serum TG >= 400 mg/dL 5) Patients who have experienced myocardial infarction or a cerebral stroke within 3 months 6) Patients with serious heart failure (NYHA class III to IV) 7) Patients who is scheduled to undergo PTCA/CABG during the study period 8) Patients with active hepatic disease (ALT or AST > 100 IU/L or total bilirubin > 2.5 mg/dL) 9) Patients with renal disorder (Cr >= 2.0 mg/dL or Ccr < 30 mL/min/1.73m2) 10) Patients with CK > 1000 IU/L 11) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder 12) Patients with drug abuse or alcoholic 13) Pregnant women, impregnable women, or those who hope to be pregnant during the study period 14) Patients who use the prohibited concomitant drugs* or who might use such drugs during the study period (* statins, fibrates, cholesterol absorption inhibitors, or probucol) 15) Patients who are ineligible in the opinion of the investigator NB: For values of the tests mentioned above, it is available to use the latest value measured within 6 months of consent agreement.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of patients who have reached JAS guideline 2007 LDL-C goal at week 8 2) Percentage change from baseline in serum lipids (HDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 8 3) Percentage change from baseline in fasting blood glucose and HbA1c at week 8 4) Percentage change from baseline in serum lipids (HDL-C, LDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 4 | — |
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction from baseline in serum LDL-C at week 8 | — |
Countries
Japan
Contacts
Public ContactASTRO-2 study support center
Mebix Inc. ASTRO-2 Study Support Center Agency Clinical Study Division
Outcome results
None listed