Trial | NCT00211705  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pravastatin ...

  • Study Participants

    8000
To evaluate the primary preventive effect of low-dose pravastatin against coronary heart disease (CHD) in Japanese hypercholesterolemic patients.
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 Started
Feb 28
1994
Study Completion
Mar 31
2004
Last Update
Dec 04
2006
Estimate

Behavioral Diet

Drug Diet+pravastatin

Criteria 

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
No Results Posted