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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152633
Recruitment Status : Withdrawn (No patient could be recruited.)
First Posted : September 9, 2005
Last Update Posted : July 6, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Losartan Drug: Metoprolol Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Study Start Date : September 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Losartan
Treatment with Losartan.
Drug: Losartan
Drug: Losartan
Treatment with Losartan

Active Comparator: Betablocker
Treatment with Metoprolol.
Drug: Metoprolol

Primary Outcome Measures :
  1. Change in retinal endothelial function

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00152633

CRC, Med. Klinik 4, University of Erlangen-Nürnberg
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Merck Sharp & Dohme Corp.
Principal Investigator: Roland E Schmieder, MD CRC, Med. Klinik 4, University of Erlangen-Nürnberg

Responsible Party: Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School Identifier: NCT00152633     History of Changes
Other Study ID Numbers: Retina-Losartan
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by Roland E. Schmieder, University of Erlangen-Nürnberg Medical School:
endothelium, hypertension, retina, AT1

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents