A Study To verify the efficacy of ROsuvastatin 2.5 mg as an aggressive lipid lowering therapy for hypercholesterolemia-1

UMIN ID: UMIN000000812

Registered date:31/08/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hypercholesterolemia
• Date of first enrollment: 2007/09/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 tablet) will be orally administered once daily for 8 weeks.

Outcome(s)

• Primary Outcome: Rate of decreases in serum LDL-C at week 8
• Secondary Outcome: 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

Key inclusion & exclusion criteria

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

Related Information

• Primary Sponsor: Graduate Scholl of Medicine, the University of Tokyo
• Source(s) of Monetary Support: None