HyperlipidemiaNCT00365742
Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements
A study testing simvastatin, red yeast rice and pharmaceutical grade fish oil in people with Hyperlipidemia, run by Chestnut Hill Health System.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- simvastatin, red yeast rice and pharmaceutical grade fish oil
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read the 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
- Conditions
- Hyperlipidemia
- Being tested
- simvastatin, red yeast rice, pharmaceutical grade fish oil, therapeutic lifestyle changes
- Keywords
- red yeast rice, pharmaceutical grade fish oil, simvastatin, primary prevention
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
red yeast riceDrug
pharmaceutical grade fish oilDrug
therapeutic lifestyle changesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-c cholesterol
Secondary outcomes (4)
total cholesterol
HDL
Triglycerides
cardiac CRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startApr 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Chestnut Hill Health System
- Sponsor type
- University, hospital or other
- Investigators
- David Becker, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365742
- Sponsor's protocol ID
- FWA00005390-Chestnut Hill Hosp
- Status last verified
- Aug 2006
- First submitted
- 16 Aug 2006
- Last updated
- 17 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Vs Therapeutic Lifestyle Changes and Supplements: A Primary Prevention Randomized Trial
- ClinicalTrials.gov ID
- NCT00365742
- Acronym / sponsor ID
- FWA00005390-Chestnut Hill Hosp
- Conditions
- Hyperlipidemia
- Keywords
- red yeast rice, pharmaceutical grade fish oil, simvastatin, primary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Chestnut Hill Health SystemUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Jun 2006
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simvastatin | Drug | – |
| red yeast rice | Drug | – |
| pharmaceutical grade fish oil | Drug | – |
| therapeutic lifestyle changes | Behavioural | – |
Primary outcome
LDL-c cholesterol
4 secondary outcomes
total cholesterol
HDL
Triglycerides
cardiac CRP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Becker principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing simvastatin, red yeast rice and pharmaceutical grade fish oil in people with Hyperlipidemia, run by Chestnut Hill Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-c cholesterol. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2006.