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Completed

NCT Number: NCT00211705

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

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

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Key information

Conditions

Hyperlipidemia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Stroke Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Behavioral

Diet+pravastatin

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Mitsukoshi Health and Welfare Foundation

Industry

Collaborators

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

Registry information

Important dates

Study start
1994
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Dec 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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