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WithdrawnNCT00152633Updated Jul 6, 2012

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

A Phase 2/3 interventional study of Losartan and Metoprolol in Hypertension, sponsored by University of Erlangen-Nürnberg Medical School. Withdrawn at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-07-06.

Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2/3, Interventional, and Treatment

Why this study was withdrawn
No patient could be recruited.
Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • endothelium, hypertension, retina, AT1
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

Browse Hypertension studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male and female patients aged 18-65 years with essential hypertension

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Losartan

    Treatment with Losartan.

    Drug: Losartan

  • Active comparator
    Betablocker

    Treatment with Metoprolol.

    Drug: Metoprolol

Interventions

06

What researchers measure

Primary outcomes

  1. Change in retinal endothelial function

07

Study locations

1 site
  • CRC, Med. Klinik 4, University of Erlangen-Nürnberg
    Erlangen, 91054, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2005, a primary completion of Jan 2006 and a completion of Jan 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2005
First posted
Sep 9, 2005
Start
Sep 2005
Primary completionActual
Jan 2006
CompletionActual
Jan 2006
Last update
Jul 6, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00152633
Lead sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Roland E. Schmieder (Prof. Dr. med., University of Erlangen-Nürnberg Medical School) — Principal investigator
First posted
Sep 9, 2005
Start date
Sep 2005
Primary completion
Jan 2006
Completion
Jan 2006
Last update
Jul 6, 2012

Study contacts

Roland E Schmieder, MD
principal investigator · CRC, Med. Klinik 4, University of Erlangen-Nürnberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Losartan · Metoprolol

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