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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211705
• Other study ID #: MEGA
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 30, 2006
• Start date: February 1994
• Est. completion date: March 2004

Study information

• Verified date: June 2005
• Source: Mitsukoshi Health and Welfare Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Behavioral:
• Diet

Drug:
• Diet+pravastatin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Mitsukoshi Health and Welfare Foundation	Daiichi Sankyo Co., Ltd., Ministry of Health, Labour and Welfare, Japan

References & Publications (2)

Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study Group. Design and baseline characteristics of a study of primary prevention of coronary events with pravastatin among Japanese with mildly elevated cholesterol levels. Circ J. 2004 Sep;68(9):860-7. — View Citation

Nakamura H, Arakawa K, Itakura H, Kitabatake A, Goto Y, Toyota T, Nakaya N, Nishimoto S, Muranaka M, Yamamoto A, Mizuno K, Ohashi Y; MEGA Study Group. Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA Study): a prospective rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
Secondary	Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality