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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00211705
Enrollment
8000
Registered
2005-09-21
Start date
1994-02-28
Completion date
2004-03-31
Last updated
2006-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia, coronary heart disease, prevention, stroke, pravastatin

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.

Interventions

BEHAVIORALDiet
DRUGDiet+pravastatin

Sponsors

Daiichi Sankyo Co., Ltd.
CollaboratorINDUSTRY
Ministry of Health, Labour and Welfare, Japan
CollaboratorOTHER_GOV
Mitsukoshi Health and Welfare Foundation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]

Secondary

MeasureTime frame
Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026