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Status: Withdrawn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
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