Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
NCT ID: NCT00988364
Last Updated: 2023-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2007-03-31
2008-02-29
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ezetimibe
Randomly chosen participants will receive ezetimibe 10mg daily for 3 months.
Ezetimibe
Ezetimibe 10mg daily for 3 months.
Simvastatin
Randomly chosen participants will receive Simvastatin 20mg daily for 3 months.
Simvastatin
Simvastatin 20mg daily for 3 months.
Vytorin
Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months.
Vytorin
Vytorin 20/10mg daily for 3 months.
Placebo
Randomly chosen participants will receive Placebo tab 1 daily for 3 months.
Placebo
Placebo one tablet daily times 3 months.
Interventions
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Simvastatin
Simvastatin 20mg daily for 3 months.
Vytorin
Vytorin 20/10mg daily for 3 months.
Placebo
Placebo one tablet daily times 3 months.
Ezetimibe
Ezetimibe 10mg daily for 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The 5 criteria are:
1. abdominal obesity (men\>40 inches, women \>35 inches);
2. TG\> 150mg/dL;
3. low HDL-C (men \< 40mg/dL, women \< 50 mg/dL);
4. high blood pressure (\>or=130/\>or=85 mmHg);
5. fasting glucose \> or = 110mg/dL.
* People with different ethnic backgrounds will be included.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Baylor College of Medicine
OTHER
Responsible Party
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Chu-Huang Chen
Principal Investigator
Principal Investigators
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Chu-Huang Chen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Christie Ballantyne, M.D.
Role: STUDY_DIRECTOR
Baylor College of Medicine
Locations
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Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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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.
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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.
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.
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.
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.
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La Belle M, Blanche PJ, Krauss RM. Charge properties of low density lipoprotein subclasses. J Lipid Res. 1997 Apr;38(4):690-700.
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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.
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van Heek M, Austin TM, Farley C, Cook JA, Tetzloff GG, Davis HR. Ezetimibe, a potent cholesterol absorption inhibitor, normalizes combined dyslipidemia in obese hyperinsulinemic hamsters. Diabetes. 2001 Jun;50(6):1330-5. doi: 10.2337/diabetes.50.6.1330.
Yang CY, Raya JL, Chen HH, Chen CH, Abe Y, Pownall HJ, Taylor AA, Smith CV. Isolation, characterization, and functional assessment of oxidatively modified subfractions of circulating low-density lipoproteins. Arterioscler Thromb Vasc Biol. 2003 Jun 1;23(6):1083-90. doi: 10.1161/01.ATV.0000071350.78872.C4. Epub 2003 Apr 10.
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Other Identifiers
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MK0653A
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-20169
Identifier Type: -
Identifier Source: org_study_id