A Study To verify the efficacy of ROsuvastatin 5 mg as an aggressive lipid lowering therapy for hypercholesterolemia (No.2)

UMIN ID: UMIN000000912

Registered date:30/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hypercholesterolemia
• Date of first enrollment: 2007/12/01
• Target sample size: 900
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 mg tablet or 2 tablets of atorvastatin 5 mg tablet) will be orally administered once daily for 8 weeks.

Outcome(s)

• Primary Outcome: Percentage reduction from baseline in serum LDL-C at week 8
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Graduate School of Medicine, the University of Tokyo
• Source(s) of Monetary Support: Japan Heart Foundation