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Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension

Information source: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Losartan (Drug); Metoprolol (Drug); Losartan (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: University of Erlangen-Nürnberg Medical School

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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

Starting date: September 2005
Last updated: July 4, 2012

Page last updated: August 20, 2015

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