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

September 13, 2005
November 30, 2006
February 1994
Not Provided
Coronary Heart Disease(CHD)[fatal/non-fatal MI, sudden/cardiac death, angina, revascularization]
Same as current
Complete list of historical versions of study NCT00211705 on ClinicalTrials.gov Archive Site
Stroke, cerebrovascular infarction(CI), CHD+CI, all cardiovascular events, total mortality
Same as current
Not Provided
Not Provided
 
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese(MEGA Study)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hyperlipidemia
  • Behavioral: Diet
  • Drug: Diet+pravastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8000
March 2004
Not Provided

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00211705
MEGA
Not Provided
Not Provided
Mitsukoshi Health and Welfare Foundation
  • Daiichi Sankyo Co., Ltd.
  • Ministry of Health, Labour and Welfare, Japan
Study Chair: Haruo Nakamura, MD Mitsukoshi Health and Welfare
Mitsukoshi Health and Welfare Foundation
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP