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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211705
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 4, 2006
Sponsor:
Collaborators:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Hyperlipidemia Behavioral: Diet Drug: Diet+pravastatin Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
Study Start Date : February 1994
Estimated Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Pravastatin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]

Secondary Outcome Measures :
  1. Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211705


Sponsors and Collaborators
Mitsukoshi Health and Welfare Foundation
Daiichi Sankyo Co., Ltd.
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Haruo Nakamura, MD Mitsukoshi Health and Welfare
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00211705     History of Changes
Other Study ID Numbers: MEGA
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: June 2005

Keywords provided by Mitsukoshi Health and Welfare Foundation:
Hyperlipidemia
coronary heart disease
prevention
stroke
pravastatin

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors