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

This study has been completed.

Sponsor:

Collaborators:

Daiichi Sankyo Co., Ltd.

Ministry of Health, Labour and Welfare, Japan

Information provided by:

Mitsukoshi Health and Welfare Foundation

ClinicalTrials.gov Identifier:

NCT00211705

First received: September 13, 2005

Last updated: November 30, 2006

Last verified: June 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 30, 2006

Start Date ^ICMJE

February 1994

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00211705 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Behavioral: Diet
Drug: Diet+pravastatin

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

8000

Completion Date

March 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00211705

Other Study ID Numbers ^ICMJE

MEGA

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Mitsukoshi Health and Welfare Foundation

Collaborators ^ICMJE

Daiichi Sankyo Co., Ltd.
Ministry of Health, Labour and Welfare, Japan

Investigators ^ICMJE

Study Chair:

Haruo Nakamura, MD

Mitsukoshi Health and Welfare

Information Provided By

Mitsukoshi Health and Welfare Foundation

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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