Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Information source: University of Erlangen-Nürnberg
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Losartan (Drug); Metoprolol (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Erlangen-Nürnberg Official(s) and/or principal investigator(s):
Roland E Schmieder, MD, Principal Investigator, Affiliation: CRC, Med. Klinik 4, University of Erlangen-Nürnberg
Summary
Essential hypertension is commonly associated with impaired endothelial function. The retinal
vasculature is morphologically and functionally related to the cerebral vessels because of
the common origin from the internal carotid artery. A recent study in hypertensive patients
demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive
patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not
clear whether this effect is due to blood pressure lowering or whether this is a blood
pressure independent effect. The present randomized, double blind study with a cross over
design addresses this issue by comparing the effects of losartan and metoprolol on retinal
endothelial function in patients with essential hypertension.
Clinical Details
Official title: Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Change in retinal endothelial function
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients aged 18-65 years with essential hypertension
Exclusion Criteria:
- Secondary forms of hypertension
- Advanced damage of vital organs (grade III and IV retinopathy)
- 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 teh exception of basal cell carcinoma of the skin
- History of allograft transplantation
- 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 or above
200% of standard.
- Patients, who are not sufficiently compliant, or patients, who are not capable or
willing to appear for controlling vistas.
- Presumed risk of transmission of HIV or hepatitis via blood from the participant
Locations and Contacts
CRC, Med. Klinik 4, University of Erlangen-Nürnberg, Erlangen 91054, Germany
Additional Information
Ending date: September 2006
Last updated: March 13, 2007
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