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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00152633
• Other study ID #: Retina-Losartan
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: July 4, 2012
• Start date: September 2005
• Est. completion date: January 2006

Study information

• Verified date: July 2012
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Losartan

• Metoprolol

• Losartan
Treatment with Losartan

Locations

Country	Name	City	State
Germany	CRC, Med. Klinik 4, University of Erlangen-Nürnberg	Erlangen

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in retinal endothelial function