HyperlipidemiaPhase 2/3LOCUSTNCT00566267
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
A Phase 2/3 study testing simvastatin 20 mg/ezetimibe in people with Hyperlipidemia, run by Merck Sharp & Dohme LLC.
Trial summary
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- simvastatin 20 mg/ezetimibe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Nov 2007
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderately obese with hyperlipidemia
Who cannot join
- Recent unstable heart or lung condition
- Current use of other lipid modifying drugs
- Hepatic disease
- Pregnancy or lactation
About this study
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.
- Conditions
- Hyperlipidemia
- Being tested
- simvastatin 20 mg/ezetimibe
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin 20 mg/ezetimibeDrug
Also called Low carb diet plus simvastatin 20 mg
see protocol
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg Receives: Drug: simvastatin 20 mg/ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Measured: 8 weeks of treatment
Secondary outcomes (2)
Other lipid measures
Measured: 8 weeks of treatment
Safety and tolerability
Measured: 8 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startApr 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frederick F Samaha, M.D., Principal investigator, Philadelphia VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566267
- Sponsor's protocol ID
- 00887
- Other IDs
- MIRB Number: 00887, PROM # 0025
- Acronym
- LOCUST
- Status last verified
- Nov 2007
- First submitted
- 29 Nov 2007
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.
PubMed 20435205
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet
- ClinicalTrials.gov ID
- NCT00566267
- Acronym / sponsor ID
- LOCUST / 00887
- Conditions
- Hyperlipidemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Dec 2007 (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.
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: simvastatin 20 mg/ezetimibeLow carb diet plus simvastatin 20 mg/ezetimibe 10 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderately obese with hyperlipidemia
Key exclusion criteria (4 listed)
- Recent unstable heart or lung condition
- Current use of other lipid modifying drugs
- Hepatic disease
- Pregnancy or lactation
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 20 mg/ezetimibeAlso: Low carb diet plus simvastatin 20 mgsee protocol | Drug | 2 |
Primary outcome
LDL cholesterol
Time frame: 8 weeks of treatment
2 secondary outcomes
Other lipid measures
Time frame: 8 weeks of treatment
Safety and tolerability
Time frame: 8 weeks treatment
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 3 Dec 2007.
- Derived from this study: PubMed 20435205Chirinos JA, Williams MM, Bregman DB, Ashfaq H, Khayyam U, Iqbal N. Efficacy of cholesterol uptake inhibition added to statin therapy among subjects following a low-carbohydrate diet: a randomized controlled trial. Am Heart J. 2010 May;159(5):918.e1-6. doi: 10.1016/j.ahj.2010.02.010.
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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.
Frederick F Samaha, M.D. principal investigator
Philadelphia VAMC
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing simvastatin 20 mg/ezetimibe in people with Hyperlipidemia, run by Merck Sharp & Dohme LLC.
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 4 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 3 Dec 2007. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 cholesterol (time frame: 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00566267, which also lists 1 linked publication.
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 3 Dec 2007.