Text Size

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

This study has been completed.
Sponsor:
Information provided by:
Chestnut Hill Health System
ClinicalTrials.gov Identifier:
NCT00365742
First received: August 16, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365742

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

No publications provided

ClinicalTrials.gov Identifier: NCT00365742     History of Changes
Other Study ID Numbers: FWA00005390-Chestnut Hill Hosp
Study First Received: August 16, 2006
Last Updated: August 16, 2006
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013