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Clinical Trial Summary

Randomized trial in a primary prevention population

- all participants have high LDL cholesterol

Group one will take simvastatin 40 mg/day Group Two will make therapeutic lifestyle changes,and take supplements consisting of red yeast rice and fish oil


Clinical Trial Description

This is a randomized primary prevention trial to compare the LDL lowering effects of an alternative regimen to statins(simvastatin) This alternative regimen is over the counter and available at health food stores. The alternative regimen consists of lifestyle changes including a Mediterranean Diet,exercise program, and stress reduction, with red yeast rice 1200 mg twice per day and fish oil 6 grams/day. The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00365742
Study type Interventional
Source Chestnut Hill Health System
Contact
Status Completed
Phase N/A
Start date April 2006
Completion date June 2006

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