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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
  Purpose

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


Condition Intervention
Hyperlipidemia Drug: simvastatin Drug: red yeast rice Drug: pharmaceutical grade fish oil Behavioral: therapeutic lifestyle changes

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

Resource links provided by NLM:


Further study details as provided by Chestnut Hill Health System:

Primary Outcome Measures:
  • LDL-c cholesterol

Secondary Outcome Measures:
  • total cholesterol
  • HDL
  • Triglycerides
  • cardiac CRP

Estimated Enrollment: 80
Study Start Date: April 2006
Estimated Study Completion Date: June 2006
Detailed 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365742


Sponsors and Collaborators
Chestnut Hill Health System
Investigators
Principal Investigator: David Becker
  More Information

ClinicalTrials.gov Identifier: NCT00365742     History of Changes
Other Study ID Numbers: FWA00005390-Chestnut Hill Hosp
First Submitted: August 16, 2006
First Posted: August 17, 2006
Last Update Posted: August 17, 2006
Last Verified: August 2006

Keywords provided by Chestnut Hill Health System:
red yeast rice
pharmaceutical grade fish oil
simvastatin
primary prevention

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Simvastatin
Red yeast rice
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors