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Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Function
This study has been completed.
First Received: September 12, 2005   Last Updated: September 15, 2005   History of Changes
Sponsored by: UMC Utrecht
Information provided by: UMC Utrecht
ClinicalTrials.gov Identifier: NCT00189085
  Purpose

In the present study we investigate the effects of the cholesterol absorption inhibitor ezetimibe on posprandial lipemia and postprandial endothelial function in patients with the metabolic syndrome. The lipid-lowering effect of high-dose statin monotherapy on fasting lipids is equal to the combination therapy of low-dose statin and ezetimibe.


Condition Intervention Phase
Metabolic Syndrome
Drug: simvastatin and ezetimibe
Phase IV

MedlinePlus related topics: Statins
Drug Information available for: Simvastatin Ezetimibe
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: The Effects of Ezetimibe on Postprandial Hyperlipidemia and Endothelial Dysfunction in Patients With the Metabolic Syndrome.

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Postprandial lipemia
  • Postprandial endothelial function

Estimated Enrollment: 20
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female (postmenopausal) patients, 18-70 years of age
  2. Diagnosis of the metabolic syndrome according to ATP III criteria(4), including 3 or more of the following metabolic abnormalities:

    • abdominal obesity (waist circumference > 102 cm in men and > 88 cm in women)
    • elevated blood pressure (³ 130 mmHg systolic or ³ 85 mmHg diastolic)
    • hypertriglyceridemia (serum triglycerides ³ 1.70 mmol/L
    • low high-density lipoprotein (HDL) cholesterol (serum HDL-cholesterol <1.04 mmol/L in men and < 1.29 mmol/L in women)
    • high fasting glucose (fasting serum glucose ³ 6.1 mmol/L)
  3. Written informed consent

Exclusion Criteria:

  1. Smoking
  2. Thyroid disease (TSH > 5 mU/L with clinical symptoms of hypothyroidism)
  3. Hepatic disease (ASAT or ALAT > 2 times the upper limit of normal)
  4. Renal disease (serum creatinine > 1.7 times the upper limit of normal).
  5. A history of coronary heart disease, cerebrovascular disease or peripheral arterial disease.
  6. Use of lipid lowering therapy
  7. Systolic blood pressure ≥ 180 mmHg and /or diastolic blood pressure ≥ 110 mmHg
  8. BMI > 35
  9. HbA1c > 6.5%
  10. Triglycerides > 8.0 mmol/L
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189085

Locations
Netherlands
Department of Vascular Medicine UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Frank LJ Visseren, MD PhD UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: EZET
Study First Received: September 12, 2005
Last Updated: September 15, 2005
ClinicalTrials.gov Identifier: NCT00189085     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Metabolic syndrome

Study placed in the following topic categories:
Antimetabolites
Metabolic Diseases
Hyperlipidemias
Simvastatin
Antilipemic Agents
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Hyperlipidemias
Metabolic Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Syndrome
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009