Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study) - Full Text View

Purpose

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

Condition	Intervention	Phase
Hyperlipidemia	Behavioral: Diet Drug: Diet+pravastatin	Phase IV

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Cholesterol Heart Diseases

ChemIDplus related topics:

Pravastatin Pravastatin sodium Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Mitsukoshi Health and Welfare Foundation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	8000
Study Start Date:	February 1994
Estimated Study Completion Date:	March 2004

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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211705

Sponsors and Collaborators

Mitsukoshi Health and Welfare Foundation

Daiichi Sankyo Co., Ltd.

Ministry of Health, Labour and Welfare

Investigators


Study Chair:	Haruo Nakamura, MD	Mitsukoshi Health and Welfare

More Information

Publications of Results:

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 randomised controlled trial. Lancet. 2006 Sep 30;368(9542):1155-63.

Other Publications:

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.

Publications indexed to this study:

Mizuno K, Nakaya N, Ohashi Y, Tajima N, Kushiro T, Teramoto T, Uchiyama S, Nakamura H; MEGA Study Group. Usefulness of pravastatin in primary prevention of cardiovascular events in women: analysis of the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA study). Circulation. 2008 Jan 29;117(4):494-502. Epub 2008 Jan 2.

Study ID Numbers:	MEGA
First Received:	September 13, 2005
Last Updated:	November 30, 2006
ClinicalTrials.gov Identifier:	NCT00211705
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsukoshi Health and Welfare Foundation:

Hyperlipidemia

coronary heart disease

prevention

stroke

pravastatin

Study placed in the following topic categories:

Coronary Disease

Pravastatin

Metabolic Diseases

Hyperlipidemias

Heart Diseases

Cerebral Infarction

Stroke

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Mitsukoshi Health and Welfare Foundation Daiichi Sankyo Co., Ltd. Ministry of Health, Labour and Welfare
Information provided by:	Mitsukoshi Health and Welfare Foundation
ClinicalTrials.gov Identifier:	NCT00211705