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This study has been withdrawn prior to enrollment.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

September 8, 2005
July 4, 2012
September 2005
January 2006   (final data collection date for primary outcome measure)
Change in retinal endothelial function
Same as current
Complete list of historical versions of study NCT00152633 on ClinicalTrials.gov Archive Site
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Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Losartan
  • Drug: Metoprolol
  • Drug: Losartan
    Treatment with Losartan
  • Active Comparator: Losartan
    Treatment with Losartan.
    Interventions:
    • Drug: Losartan
    • Drug: Losartan
  • Active Comparator: Betablocker
    Treatment with Metoprolol.
    Intervention: Drug: Metoprolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2006
January 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00152633
Retina-Losartan
No
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
University of Erlangen-Nürnberg Medical School
Merck
Principal Investigator: Roland E Schmieder, MD CRC, Med. Klinik 4, University of Erlangen-Nürnberg
University of Erlangen-Nürnberg Medical School
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP