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This study has been withdrawn prior to enrollment.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.)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
First received: September 8, 2005
Last updated: July 4, 2012
Last verified: July 2012
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.
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension
Primary Outcome Measures:
- Change in retinal endothelial function
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2006 (Final data collection date for primary outcome measure)
Active Comparator: Losartan
Treatment with Losartan.
Treatment with Losartan
Active Comparator: Betablocker
Treatment with Metoprolol.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female patients aged 18-65 years with essential hypertension
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00152633
|CRC, Med. Klinik 4, University of Erlangen-Nürnberg
|Erlangen, Germany, 91054 |
University of Erlangen-Nürnberg Medical School
Merck Sharp & Dohme Corp.
||Roland E Schmieder, MD
||CRC, Med. Klinik 4, University of Erlangen-Nürnberg
No publications provided
||Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2005
||July 4, 2012
||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:
ClinicalTrials.gov processed this record on September 18, 2014
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists