A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2)
- Conditions
- hypercholesterolemia
- Registration Number
- JPRN-UMIN000000912
- Lead Sponsor
- Graduate School of Medicine, the University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 900
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method