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OpenTrials
Completed

NCT Number: NCT00365742

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

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

Completed

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults ages 18-75 yrs, who meet ATP III criteria to be treated for high cholesterol. All participants must be able to exercise and be willing to be randomized to either arm of the study

Exclusion criteria

  • No history of bypass surgery, stents, or hx of myocardial infarction. Cannot have uncontrolled hypertension(SBP>190 or DBP>100), cannot have known intolerance to one of the study drug

Treatment and study plan

simvastatin

Drug

red yeast rice

Drug

pharmaceutical grade fish oil

Drug

therapeutic lifestyle changes

Behavioral

Primary outcomes

  1. LDL-c cholesterol

Secondary outcomes

  1. total cholesterol

  2. HDL

  3. Triglycerides

  4. cardiac CRP

Sponsors and collaborators

Lead sponsor

Chestnut Hill Health System

Other

Registry information

Official study title

Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

Important dates

Study start
2006
Study completion
2006
First posted
Aug 17, 2006
Registry last updated
Aug 17, 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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