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

Phase 4

Completed

• Conditions: Hyperlipidemia

• Registration Number: NCT00211705
• Lead Sponsor: Mitsukoshi Health and Welfare Foundation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 1994-02
• Study Completion: 2004-03
• Status Verified: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Last Update Submitted: 2006-11-30
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]

Secondary Outcome Measures

Name	Time	Method
Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality