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Metabolic SyndromePhase 4Merck-123NCT00988364

Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.

A Phase 4 study testing Simvastatin, Vytorin and Ezetimibe in people with Metabolic Syndrome, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is: To identify the common factor for L5 prevalence in patients with Metabolic Syndrome. To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metabolic Syndrome
What is being tested?
Simvastatin, Vytorin and Ezetimibe
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Mar 2007to Feb 2008
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants who meet 3 or more of the 5 criteria specified in the ATPIII guidelines will be recruited.
  • The 5 criteria are:
  • abdominal obesity (men>40 inches, women >35 inches);
  • TG> 150mg/dL;
  • low HDL-C (men < 40mg/dL, women < 50 mg/dL);
  • high blood pressure (>or=130/>or=85 mmHg);
  • fasting glucose > or = 110mg/dL.
  • People with different ethnic backgrounds will be included.

Who cannot join

  • symptomatic coronary artery disease
  • peripheral vascular disease
  • cerebral ischemia (stroke)
  • smoking
  • hypothyroidism
  • kidney diseases
  • consumption of antioxidation supplements/drugs or use of lipid-lowering drugs in the last 3 months
  • women who are pregnant, nursing, or planning to become pregnant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 in Patients With Metabolic Syndrome

The purpose of this study is:

  • To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
  • To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients.
Read the detailed description

Epidemiological evidence indicates that metabolic syndrome (MS) is a strong predisposing condition for atherosclerosis. Elevation of plasma low-density lipoprotein (LDL) cholesterol(LDL-C) concentration is the most important risk factor for atherosclerosis; however, LDL-C elevation is not a criterion for metabolic syndrome, raising the question of LDL's role in the syndrome's association with atherosclerosis. L5, a highly electronegative and mildly oxidized LDL subfraction that we recently isolated from hypercholesterolemic human plasma, may provide a key to answering this question. In cultured vascular endothelial cells (EC), L5 inhibits proliferation and induces apoptosis and monocyte-EC adhesion. In our preliminary studies, L5 could also be detected in patients with MS without elevated LDL-C. Because other LDL subfractions were harmless to EC, the presence of MS-L5 prompted us to hypothesize that the atherogenic role of LDL is not solely determined by plasma LDL-C concentration, but more importantly, by its composition. The proposed study is designed to test this hypothesis. The first question we will address is what lipid factor determines the prevalence of L5 in MS.

Subsequently, we will examine whether treatment with selected medicines can effectively reduce L5 in MS patients by correcting the factor favorable for L5 formation.

We are in the process of identifying the active components of L5 to fully characterize the atherogenic role of L5 in MS,. In the current proposal, we focus our interest on the efficacy of Ezetimibe, Simvastatin, and Vytorin in reducing L5 from the plasma of MS patients.

Being tested
Simvastatin, Vytorin, Placebo, Ezetimibe
Keywords
Metabolic Syndrome, LDL subfraction L5, The reduction of LDL in patients with Metabolic Syndrome, The prevalence of L5 in patients with Metabolic Syndrome, The reduction of L5 in patients with Metabolic Syndrome
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SimvastatinDrug

    Also called Zocor

    Simvastatin 20mg daily for 3 months.

  • VytorinDrug

    Also called Ezetimibe/Simvastatin

    Vytorin 20/10mg daily for 3 months.

  • PlaceboDrug

    Also called Control

    Placebo one tablet daily times 3 months.

  • EzetimibeDrug

    Also called Zetia

    Ezetimibe 10mg daily for 3 months.

Study groups in NCT00988364
Study groupRoleWhat they receive
EzetimibeActive comparatorRandomly chosen participants will receive ezetimibe 10mg daily for 3 months.
Receives: Drug: Ezetimibe
SimvastatinActive comparatorRandomly chosen participants will receive Simvastatin 20mg daily for 3 months.
Receives: Drug: Simvastatin
VytorinActive comparatorRandomly chosen participants will receive Vytorin 20/10mg daily for 3 months.
Receives: Drug: Vytorin
PlaceboPlacebo comparatorRandomly chosen participants will receive Placebo tab 1 daily for 3 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. L5 Concentration in Metabolic Syndrome Patients

    Patient's blood samples were collected before treatment. L5 were purified by ultracentrifugation then FPLC. Quantification analysis will indicate the L5 concentration (mg/dL) per group.

    Measured: 0 months, at the start

Secondary outcomes (1)

  1. L5 Concentration After Treatment of Ezetimibe, Simvastatin, or Vytorin in Metabolic Syndrome Patients

    Patient's blood samples were collected at the corresponding time point for L5 purification. L5 quantification and characterization were investigated with chemical analysis, proteomics and in-vitro cell signaling analysis. Final data analysis will determine total L5 concentration (mg/dL).

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study startMar 2007
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

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
Parallel groups
Model description
Randomized, placebo-controlled clinical trial with 4 arms
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988364
Sponsor's protocol ID
H-20169
Other IDs
MK0653A
Acronym
Merck-123
Status last verified
Nov 2023
First submitted
1 Oct 2009
Last updated
30 Nov 2023
Data monitoring committee
Yes

Publications

  • Avogaro P, Cazzolato G, Bittolo-Bon G. Some questions concerning a small, more electronegative LDL circulating in human plasma. Atherosclerosis. 1991 Nov;91(1-2):163-71. doi: 10.1016/0021-9150(91)90198-c.

    PubMed 1811552

  • Ballantyne CM, Houri J, Notarbartolo A, Melani L, Lipka LJ, Suresh R, Sun S, LeBeaut AP, Sager PT, Veltri EP; Ezetimibe Study Group. Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial. Circulation. 2003 May 20;107(19):2409-15. doi: 10.1161/01.CIR.0000068312.21969.C8. Epub 2003 Apr 28.

    PubMed 12719279

  • Ballantyne CM, Hoogeveen RC, Bang H, Coresh J, Folsom AR, Heiss G, Sharrett AR. Lipoprotein-associated phospholipase A2, high-sensitivity C-reactive protein, and risk for incident coronary heart disease in middle-aged men and women in the Atherosclerosis Risk in Communities (ARIC) study. Circulation. 2004 Feb 24;109(7):837-42. doi: 10.1161/01.CIR.0000116763.91992.F1. Epub 2004 Feb 2.

    PubMed 14757686

  • Chan DC, Watts GF, Barrett PH, Mamo JC, Redgrave TG. Markers of triglyceride-rich lipoprotein remnant metabolism in visceral obesity. Clin Chem. 2002 Feb;48(2):278-83.

    PubMed 11805008

  • Chen CH, Jiang T, Yang JH, Jiang W, Lu J, Marathe GK, Pownall HJ, Ballantyne CM, McIntyre TM, Henry PD, Yang CY. Low-density lipoprotein in hypercholesterolemic human plasma induces vascular endothelial cell apoptosis by inhibiting fibroblast growth factor 2 transcription. Circulation. 2003 Apr 29;107(16):2102-8. doi: 10.1161/01.CIR.0000065220.70220.F7. Epub 2003 Apr 14.

    PubMed 12695302

  • Chen CH, Pace PW, Karakoc ND, Lu J, Chen HH, Henry PD, Pownall HJ Foreyt JP, Ballantyne CM, Yang CY. Effective reduction of novel atherogenic LDL subfraction by atorvastatin in patients with hypercholesteremia. J AM Coll Cardiol. 2004:43(suppl A):486A (Abstract)

  • Chappey B, Myara I, Benoit MO, Maziere C, Maziere JC, Moatti N. Characteristics of ten charge-differing subfractions isolated from human native low-density lipoproteins (LDL). No evidence of peroxidative modifications. Biochim Biophys Acta. 1995 Dec 7;1259(3):261-70. doi: 10.1016/0005-2760(95)00172-7.

    PubMed 8541333

  • De Castellarnau C, Sanchez-Quesada JL, Benitez S, Rosa R, Caveda L, Vila L, Ordonez-Llanos J. Electronegative LDL from normolipemic subjects induces IL-8 and monocyte chemotactic protein secretion by human endothelial cells. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2281-7. doi: 10.1161/01.atv.20.10.2281.

    PubMed 11031216

  • Demuth K, Myara I, Chappey B, Vedie B, Pech-Amsellem MA, Haberland ME, Moatti N. A cytotoxic electronegative LDL subfraction is present in human plasma. Arterioscler Thromb Vasc Biol. 1996 Jun;16(6):773-83. doi: 10.1161/01.atv.16.6.773.

    PubMed 8640405

  • Kleinman Y, Krul ES, Burnes M, Aronson W, Pfleger B, Schonfeld G. Lipolysis of LDL with phospholipase A2 alters the expression of selected apoB-100 epitopes and the interaction of LDL with cells. J Lipid Res. 1988 Jun;29(6):729-43.

    PubMed 2459282

  • La Belle M, Blanche PJ, Krauss RM. Charge properties of low density lipoprotein subclasses. J Lipid Res. 1997 Apr;38(4):690-700.

    PubMed 9144084

  • Lee SJ, Campos H, Moye LA, Sacks FM. LDL containing apolipoprotein CIII is an independent risk factor for coronary events in diabetic patients. Arterioscler Thromb Vasc Biol. 2003 May 1;23(5):853-8. doi: 10.1161/01.ATV.0000066131.01313.EB. Epub 2003 Mar 13.

    PubMed 12637336

  • Libby P. Inflammation in atherosclerosis. Nature. 2002 Dec 19-26;420(6917):868-74. doi: 10.1038/nature01323.

    PubMed 12490960

  • Sanchez-Quesada JL, Benitez S, Ordonez-Llanos J. Electronegative low-density lipoprotein. Curr Opin Lipidol. 2004 Jun;15(3):329-35. doi: 10.1097/00041433-200406000-00014.

    PubMed 15166790

  • Sevanian A, Bittolo-Bon G, Cazzolato G, Hodis H, Hwang J, Zamburlini A, Maiorino M, Ursini F. LDL- is a lipid hydroperoxide-enriched circulating lipoprotein. J Lipid Res. 1997 Mar;38(3):419-28.

    PubMed 9101423

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Simvastatin, Vytorin and Ezetimibe in people with Metabolic Syndrome, run by Baylor College of Medicine at 1 site 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 8 inclusion and 8 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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 30 Nov 2023). 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?

L5 Concentration in Metabolic Syndrome Patients (time frame: 0 months, at the start). 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 NCT00988364, which also lists 20 linked publications.

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 30 Nov 2023.

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