Status:
WITHDRAWN
Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypercholesterolemia
Eligibility:
MALE
18-65 years
Phase:
PHASE3
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-depe...
Detailed Description
see above
Eligibility Criteria
Inclusion
- Male patients aged 18-65 years with LDL-cholesterol \>= 130mg/dl
- Male healthy control subjects aged 18-65 years
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00152698
Start Date
November 1 2009
End Date
December 1 2009
Last Update
December 16 2024
Active Locations (1)
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1
CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
Erlangen, Bavaria, Germany, 91054