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

Arm | Intervention/treatment |
---|---|
Active Comparator: Irbesartan |
Drug: Irbesartan |
Placebo Comparator: Placebo |
- Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
- Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients

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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 |
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

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
Germany | |
CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg | |
Erlangen, Bavaria, Germany, 91054 |
Principal Investigator: | Roland E Schmieder, MD | CRC, Medizinische Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg |
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 |
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 |