Metabolic SyndromePhase 4NCT00819403
Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment
A Phase 4 study testing simvastatin and ezetimibe/simvastatin in people with Metabolic Syndrome, run by University of Maryland, Baltimore at 3 sites in United States.
Trial summary
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- simvastatin and ezetimibe/simvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2009to Nov 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women greater than or equal to 21 years of age
- Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
- abdominal obesity, given as waist circumference for men > 102 cm, and for women > 88 cm
- triglycerides > 150 mg/dL
- HDL cholesterol < 40 mg/dL for men, and < 50 mg/dL for women
- blood pressure > 130/85 mm Hg
- fasting glucose > 100 mg/dL
Who cannot join
- Patients will be excluded for a history of bleeding diathesis
- drug or alcohol abuse
- prothrombin time greater than 1.5 times control
- platelet count < 100,000/mm3
- hematocrit < 25%
- creatinine > 4.0 mg/dl
Show all 13Show fewer
- surgery or angioplasty performed within 3 months or planned for the future
- history of gastrointestinal or other bleeding
- history of drug-induced disorders
- trauma, cancer, rheumatic diseases, coronary artery disease or stroke
- Patients participating in other investigational drug trials within one month of completion will be also excluded
- Patients treated with intravenous platelet glycoprotein IIb/IIIa inhibitors or thienopyridines, within past 6 months
- Patients treated with statins or aspirin within past four weeks
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Maryland Health Care System
Baltimore, Maryland, 21201
University of Maryland Medical Center
Baltimore, Maryland, 21202
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
Read the detailed description
- To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome.
- To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-platelet agents including aspirin, clopidogrel, intravenous and oral glycoprotein IIb/IIIa inhibitors.
- To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.
- Conditions
- Metabolic Syndrome
- Being tested
- simvastatin, ezetimibe/simvastatin
- Keywords
- triglycerides, hypertension, low hdl, obesity
- Medical subject headings
- Metabolic Syndrome, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called zocor
Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
ezetimibe/simvastatinDrug
Also called vytorin
Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Active comparator | Simvastatin 40 mg daily Receives: Drug: simvastatin |
| simvastatin/ezetimibe | Active comparator | Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Receives: Drug: ezetimibe/simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
Measured using whole blood flow cytometry
Measured: 6 weeks
Secondary outcomes (1)
Biomarkers of Inflammation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Michael Miller, University of Maryland, Baltimore
- Investigators
- MICHAEL MILLER, MD, Principal investigator, University of Maryland, College ParkVICTOR L. Serebruany, MD, PhD, Study director, President, HeartDrug Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819403
- Sponsor's protocol ID
- HP-00040970
- Other IDs
- MSP-JV IISP #32031
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2009
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ezetimibe/Simvastatin Versus Simvastatin Alone on Platelet and Inflammatory Biomarkers in Patients With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00819403
- Acronym / sponsor ID
- HP-00040970
- Conditions
- Metabolic Syndrome
- Keywords
- triglycerides, hypertension, low hdl, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Posted 18 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
Detailed description
- To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome.
- To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-platelet agents including aspirin, clopidogrel, intravenous and oral glycoprotein IIb/IIIa inhibitors.
- To determine whether the addition of ezetimibe will yield extra protection beyond lipid modulation in the reduction of inflammation and platelet activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Active comparator | Drug: simvastatinSimvastatin 40 mg daily |
| simvastatin/ezetimibe | Active comparator | Drug: ezetimibe/simvastatinSubjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women greater than or equal to 21 years of age
- Diagnosis of metabolic syndrome. We defined the presence of metabolic syndrome based on the US National Cholesterol Education Program's Adult Treatment Panel III guidelines. Specifically, metabolic syndrome will be diagnosed and documented when 3 of the following 5 characteristics will be present:
Key exclusion criteria (13 listed)
- Patients will be excluded for a history of bleeding diathesis
- drug or alcohol abuse
- prothrombin time greater than 1.5 times control
- platelet count < 100,000/mm3
- hematocrit < 25%
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 |
|---|---|---|
| simvastatinAlso: zocorSubjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. | Drug | simvastatin |
| ezetimibe/simvastatinAlso: vytorinSubjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied. | Drug | simvastatin/ezetimibe |
Primary outcome
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression
Time frame: 6 weeks
Measured using whole blood flow cytometry
1 secondary outcome
Biomarkers of Inflammation
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
MICHAEL MILLER, MD principal investigator
University of Maryland, College Park
VICTOR L. Serebruany, MD, PhD study director
President, HeartDrug Research LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing simvastatin and ezetimibe/simvastatin in people with Metabolic Syndrome, run by University of Maryland, Baltimore at 3 sites in United States.
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 7 inclusion and 13 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ex Vivo Effects of Treatment With Vytorin Versus Zocor for 6 Weeks on Platelet Alpha Thrombin PAR-1 Receptor Expression (time frame: 6 weeks). 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 14 Jan 2020.