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Sponsored by: |
UMC Utrecht |
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Information provided by: | UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT00817843 |
The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.
Condition | Intervention | Phase |
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Metabolic Syndrome |
Drug: Simvastatin / Ezetimibe Drug: Simvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | A Multicenter, Double Blind, Randomized, 2-Period, Crossover Study to Compare the Effects of Ezetimibe/Simvastatin (10 mg/10 mg) Combination Tablet Versus Simvastatin 80 mg Tablet on Postprandial Arterial Endothelial Function in Patients With Metabolic Syndrome |
Estimated Enrollment: | 100 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Simvastatin / Ezetimibe
Treatment with a combination of simvastatin 10 mg and ezetimibe 10 mg, once daily (together with a placebo for the active comparator), during 6 weeks
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2: Active Comparator |
Drug: Simvastatin
Treatment with simvastatin 80 mg, once daily (together with a placebo for the experimental drug), during 6 weeks
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Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin alone, has a beneficial effect on the lipid levels after a meal, but more importantly, whether we can measure a difference in function of the endothelium. In a small pilot study we already found that the combination had a beneficial effect in comparison with simvastatin alone. Now we want to solidify these findings in a larger study.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Patient has a diagnosis of metabolic syndrome according to the modified 2005 AHA/NHLBI Scientific Statement with at least:
Abdominal obesity defined as:
and two of the following 4 other criteria for the metabolic syndrome:
HDL Cholesterol
Blood pressure
EXCLUSION CRITERIA:
Patient has exclusionary laboratory values at Visit 1 (Week -2) as listed in the table below:
liver transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) > 1.5 X ULN with no active liver disease Serum glucose > 7.0 mmol/L (>126 mg/dL) Creatine kinase(CK)> 2 X ULN Albumin:creatinine ratio > 34 TSH <0.3 mcIU/mL or > 5.0 mcIU/mL
Patient has estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 based on the 4-variable (age, race, gender and creatinine) MDRD (Modification of Diet in Renal Disease) equation at Visit 1 (as done by the central lab), history of nephrotic syndrome or other clinically significant renal disease at Visit 1 (Week
Netherlands | |
Academic Medical Center | |
Amsterdam, Netherlands, 1005 AZ | |
Westfries Gasthuis | |
Hoorn, Netherlands, 1624 NP | |
Tweesteden Ziekenhuis | |
Waalwijk, Netherlands, 5141 BM | |
Department of Vascular Medicine UMC Utrecht | |
Utrecht, Netherlands, 3584 CX | |
Spain | |
Hospital Arnau de Vilanova | |
Lleida, Spain, E-25198 |
Principal Investigator: | Frank LJ Visseren, MD PhD | University Medical Center Utrecht |
Responsible Party: | UMC Utrecht ( F.L.J. Visseren, MD PhD ) |
Study ID Numbers: | Vasc-UMCU-10B, EUdraCT 2008-003908-61 |
Study First Received: | January 6, 2009 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00817843 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Spain: Spanish Agency of Medicines |
Postprandial hypertriglyceridemia Metabolic syndrome Endothelial function Flow mediated dilatation |
EndoPAT Simvastatin Ezetimibe |
Antimetabolites Hypertriglyceridemia Dilatation, Pathologic Simvastatin |
Antilipemic Agents Ezetimibe Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Antimetabolites Disease Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Ezetimibe Enzyme Inhibitors |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses |