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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Irbesartan
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Irbesartan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects

Secondary Outcome Measures

Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients

Full Information

First Posted
September 8, 2005
Last Updated
July 10, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00152698
Brief Title
Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irbesartan
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Primary Outcome Measure Information:
Title
Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
Secondary Outcome Measure Information:
Title
Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, MD
Organizational Affiliation
CRC, Medizinische Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30231923
Citation
Kannenkeril D, Bosch A, Harazny J, Karg M, Jung S, Ott C, Schmieder RE. Early vascular parameters in the micro- and macrocirculation in type 2 diabetes. Cardiovasc Diabetol. 2018 Sep 19;17(1):128. doi: 10.1186/s12933-018-0770-4.
Results Reference
derived
PubMed Identifier
29268712
Citation
Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
Results Reference
derived
PubMed Identifier
27306560
Citation
Jumar A, Harazny JM, Ott C, Kistner I, Friedrich S, Schmieder RE. Improvement in Retinal Capillary Rarefaction After Valsartan Treatment in Hypertensive Patients. J Clin Hypertens (Greenwich). 2016 Nov;18(11):1112-1118. doi: 10.1111/jch.12851. Epub 2016 Jun 16.
Results Reference
derived

Learn more about this trial

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

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