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

This study has been withdrawn prior to enrollment.
(No patient could be recruited.)
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00152633
First received: September 8, 2005
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  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 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in retinal endothelial function

Enrollment: 0
Study Start Date: September 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Losartan
Treatment with Losartan.
 Drug: Losartan Drug: Losartan
Treatment with Losartan
Active Comparator: Betablocker
Treatment with Metoprolol.
 Drug: Metoprolol

  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: Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00152633     History of Changes
Other Study ID Numbers: Retina-Losartan
Study First Received: September 8, 2005
Last Updated: July 4, 2012
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 May 16, 2013