Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

Mitsukoshi Health and Welfare Foundation

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemia

Treatments: Behavioral: Diet; Drug: Diet+pravastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00211705

MEGA

Details and patient eligibility

About

To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.

Full description

MEGA Study is the first prospective, randomized, controlled trial conducted in Japan to evaluate the primary preventive effect of pravastatin against CHD in daily clinical practice. Because the dose of pravastatin used in the MEGA Study was 10-20 mg/day, which is consistent with the approved doses in Japan and lower than the doses used in previous large-scale clinical trials.

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TC:220～270mg/dl
• Male: 40-70 years old/ female: postmenopausal-70 years old
• <40kg in weight

Exclusion criteria

• FH
• History of CHD(angina, MI, post-PTCA/CABG, etc.)
• History of CVA(stroke, TIA, etc.)
• Underlying malignant tumor

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)