|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | UMC Utrecht |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00817843 |
Purpose
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 |
|---|---|---|
|
Metabolic Syndrome |
Drug: Simvastatin / Ezetimibe Drug: Simvastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
Other Names:
|
| Active Comparator: 2 |
Drug: Simvastatin
Treatment with simvastatin 80 mg, once daily (together with a placebo for the experimental drug), during 6 weeks
Other Name: Zocor
|
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.
Eligibility| 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
Contacts and Locations| Netherlands | |
| Academic Medical Center | |
| Amsterdam, Netherlands, 1005 AZ | |
| Vascular Research Center Hoorn | |
| Hoorn, Netherlands, 1624 NP | |
| Department of Vascular Medicine UMC Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Tweesteden Ziekenhuis | |
| Waalwijk, Netherlands, 5141 BM | |
| Spain | |
| Hospital Arnau de Vilanova | |
| Lleida, Spain, E-25198 | |
| Principal Investigator: | Frank LJ Visseren, MD PhD | UMC Utrecht |
More Information
| Responsible Party: | F.L.J. Visseren, MD PhD, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00817843 History of Changes |
| Other Study ID Numbers: | Vasc-UMCU-10B, EUdraCT 2008-003908-61 |
| Study First Received: | January 6, 2009 |
| Last Updated: | November 2, 2010 |
| 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 |
|
Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Simvastatin Ezetimibe Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |