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

This study has been completed.

First Received on September 8, 2005. Last Updated on February 1, 2010 History of Changes

Sponsor:	University of Erlangen-Nürnberg Medical School
Collaborator:	Merck
Information provided by:	University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:	NCT00152633

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Losartan Drug: Metoprolol	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Losartan Metoprolol fumarate Losartan potassium

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:

Change in retinal endothelial function

Estimated Enrollment:	50
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152633

Locations

Germany
CRC, Med. Klinik 4, University of Erlangen-Nürnberg
Erlangen, Germany, 91054

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Merck

Investigators

Principal Investigator:

Roland E Schmieder, MD

CRC, Med. Klinik 4, University of Erlangen-Nürnberg

More Information

No publications provided

Responsible Party:	Prof. Dr. Roland E. Schmieder, University Hospital Erlangen
ClinicalTrials.gov Identifier:	NCT00152633 History of Changes
Other Study ID Numbers:	Retina-Losartan
Study First Received:	September 8, 2005
Last Updated:	February 1, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:

endothelium, hypertension, retina, AT1

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Losartan
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on February 09, 2012