Hypercholesterolemia
Conditions
Interventions
Rosuvastatin 2.5mg (1 tablet of rosuvastatin 2.5 mg tablet) will be orally administered once daily for 8 weeks.
Pravastatin 10 mg (1 tablet of pravastatin 10 mg tablet or 2 tablets of pravastatin 5 mg
Sponsors
Graduate Scholl of Medicine, the University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who are not received statin therapy within past 2 months at the time of submitting written consent agreement 2) Patients with serum LDL-C lower than the target value specified in JAS-GL2007 who have LDL-C<180 mg/dL and are not complicated with or history of coronary artery diseases (*use the latest value measured under a fasting condition within 6 months of consent agreement. If no measured values are available, values calculated by Friedewald's formula 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>=180 mmHg or DBP>=110 mmHg) 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 cerebrovascular diseases within 3 months 6) Patients with serious heart failure (NYHA class III to IV) 7) Patients undergoing 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/1.73 m2) 10) Patients with CK>1000 IU/L 11) Pregnant women, impregnable women, or those who hope to be pregnant during the study period 12) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder 13) Patients with drug abuse or alcoholism 14) Patients who use prohibited concomitant drugs* or who might use such drugs during the study period 15) Patients who are ineligible in the opinion of the investigator *Statines, fibrates, anion exchange resin, cholesterol absorption inhibitors, probucol, nicotine acids, phytosterol, other anti hypercholesterolaemia drugs, immune suppressing drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of decreases in serum LDL-C at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Ratio of patients who have reached the target serum LDL-C value specified in JASGL2007 at week 8. 2) Rates of changes in serum lipid parameter (HDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 8. 3) Rates of changes in fasting blood glucose and HbA1c at week 8. 4) Rates of changes in serum lipid parameter (HDL-C, LDL-C, TG, ApoB, ApoA-1, ApoB/ApoA-1 ratio, LDL-C/HDL-C ratio) at week 4 | — |
Countries
Japan
Contacts
Public ContactASTRO-1 study support center
Mebix Inc. ASTRO-1 study support center agency Clinical study division
Outcome results
None listed