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

Primary Purpose

Hypertension

Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Losartan
Metoprolol
Losartan
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring endothelium, hypertension, retina, AT1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Losartan

Betablocker

Arm Description

Treatment with Losartan.

Treatment with Metoprolol.

Outcomes

Primary Outcome Measures

Change in retinal endothelial function

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
July 4, 2012
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00152633
Brief Title
Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Official Title
Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No patient could be recruited.
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
endothelium, hypertension, retina, AT1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Active Comparator
Arm Description
Treatment with Losartan.
Arm Title
Betablocker
Arm Type
Active Comparator
Arm Description
Treatment with Metoprolol.
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Treatment with Losartan
Primary Outcome Measure Information:
Title
Change in retinal endothelial function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, MD
Organizational Affiliation
CRC, Med. Klinik 4, University of Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC, Med. Klinik 4, University of Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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

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