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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Japan
Investigators
Study Chair: Haruo Nakamura, MD Mitsukoshi Health and Welfare
  More Information

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

ClinicalTrials.gov Identifier: NCT00211705     History of Changes
Other Study ID Numbers: MEGA
Study First Received: September 13, 2005
Last Updated: November 30, 2006
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:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014