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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00152698
First received: September 8, 2005
Last updated: January 18, 2013
Last verified: January 2013
History of Changes

September 8, 2005
January 18, 2013
November 2009
December 2009   (final data collection date for primary outcome measure)
Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
Same as current
Complete list of historical versions of study NCT00152698 on ClinicalTrials.gov Archive Site
Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients
Same as current
Not Provided
Not Provided
 
Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia
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

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.

see above
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
Drug: Irbesartan
  • Active Comparator: Irbesartan
    Intervention: Drug: Irbesartan
  • Placebo Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00152698
Retina-Irbesartan
No
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Bristol-Myers Squibb
Principal Investigator: Roland E Schmieder, MD CRC, Medizinische Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
University of Erlangen-Nürnberg Medical School
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP