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Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT00152698
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : January 21, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School

Study Description
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Brief Summary:
The retinal vasculature is morphologically and functionally related to the cerebral vessels due to its common origin from the internal carotid artery. A recent study demonstrated that endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and impairment of endothelial function has been observed in various vascular beds in hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether endothelial function of the retinal vasculature is impaired in patients with hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical outcome. Alterations of endothelial function of the cerebral vasculature might be one pathogenetic factor for the beneficial clinical outcome. To further address this issue, the present study was designed to test the hypothesis that endothelium-dependent vasodilation of the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial function can be improved by AT1-receptor blockade.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Irbesartan Phase 3

Detailed Description:
see above
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Study the Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia
Study Start Date : November 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Irbesartan Drug: Irbesartan
Placebo Comparator: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects

Secondary Outcome Measures :
  1. Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male patients aged 18-65 years with LDL-cholesterol >= 130mg/dl
  • Male healthy control subjects aged 18-65 years

Exclusion Criteria:

  • All kinds of secondary hyperlipidemia.
  • Advanced damage of vital organs (grades III and IV retinopathy)
  • Lipid-lowering drugs (including lipid lowering dietary supplements or food additives) within the last 4 weeks
  • History of serious hypersensitivity reaction to AT1-receptor blockers
  • Actual or anamnestic alcohol- or drug abuse.
  • Smokers or ex-smokers < 1 year.
  • Patients with Diabetes mellitus (oral medication or insulin).
  • Patients with arterial fibrillation or AV-Block (II° or more).
  • Patients with anamnestic myocardial infarction.
  • Patients with instable angina pectoris including EcG-aberrations or cardiac insufficiency NYHA III or IV.
  • History of malignancy (unless a documented disease-free period exceeding 10 years is present) with the exception of basal cell carcinoma of the skin
  • History of allograft transplantation
  • Patients with anaphylaxis or known therapy resistance of the used test matters
  • Therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start.
  • Disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
  • Liver or kidney disease with SGOT, GPT, g-GT, AP, bilirubin and creatinin above 200% of standard.
  • Patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling visits.
  • Presumed risk of transmission of HIV or hepatitis via blood from the proband
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152698


Locations
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Germany
CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Bristol-Myers Squibb
Investigators
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Principal Investigator: Roland E Schmieder, MD CRC, Medizinische Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00152698    
Other Study ID Numbers: Retina-Irbesartan
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action