- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00365742
Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
August 16, 2006 updated by: Chestnut Hill Health System
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
Study Overview
Status
Completed
Conditions
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
Study Type
Interventional
Enrollment
80
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
LDL-c cholesterol
|
Secondary Outcome Measures
Outcome Measure |
---|
Triglycerides
|
total cholesterol
|
HDL
|
cardiac CRP
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Becker
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
August 16, 2006
First Submitted That Met QC Criteria
August 16, 2006
First Posted (Estimate)
August 17, 2006
Study Record Updates
Last Update Posted (Estimate)
August 17, 2006
Last Update Submitted That Met QC Criteria
August 16, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
- Red yeast rice
Other Study ID Numbers
- FWA00005390-Chestnut Hill Hosp
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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