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

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

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

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)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diets Heart Diseases

Drug Information available for: Pravastatin Pravastatin sodium

U.S. FDA Resources

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:

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.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nakamura H, Mizuno K, Ohashi Y, Yoshida T, Hirao K, Uchida Y; MEGA Study Group. Pravastatin and cardiovascular risk in moderate chronic kidney disease. Atherosclerosis. 2009 Oct;206(2):512-7. Epub 2009 Apr 5.

Kushiro T, Mizuno K, Nakaya N, Ohashi Y, Tajima N, Teramoto T, Uchiyama S, Nakamura H; Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese Study Group. Pravastatin for cardiovascular event primary prevention in patients with mild-to-moderate hypertension in the Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Study. Hypertension. 2009 Feb;53(2):135-41. Epub 2008 Dec 22.

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

Keywords provided by Mitsukoshi Health and Welfare Foundation:

Hyperlipidemia
coronary heart disease
prevention
stroke
pravastatin

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pravastatin
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 05, 2009