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Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00365742
First Posted: August 17, 2006
Last Update Posted: August 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chestnut Hill Health System
August 16, 2006
August 17, 2006
August 17, 2006
April 2006
Not Provided
LDL-c cholesterol
Same as current
No Changes Posted
  • total cholesterol
  • HDL
  • Triglycerides
  • cardiac CRP
Same as current
Not Provided
Not Provided
 
Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

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

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Hyperlipidemia
  • Drug: simvastatin
  • Drug: red yeast rice
  • Drug: pharmaceutical grade fish oil
  • Behavioral: therapeutic lifestyle changes
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
June 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00365742
FWA00005390-Chestnut Hill Hosp
Not Provided
Not Provided
Not Provided
Not Provided
Chestnut Hill Health System
Not Provided
Principal Investigator: David Becker
Chestnut Hill Health System
August 2006

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