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

NCT00152633 | Withdrawn Phase 2

• 1 other identifier: Retina-Losartan
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

endothelium, hypertension, retina, AT1

Outcome Measures

Primary Outcomes (1)

• Change in retinal endothelial function

Study Arms (2)

Losartan

ACTIVE COMPARATOR

Treatment with Losartan.

Drug: Losartan

Betablocker

ACTIVE COMPARATOR

Treatment with Metoprolol.

Drug: Metoprolol

Interventions

Losartan DRUG

Losartan

Metoprolol DRUG

Betablocker

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

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

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Metoprolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines

Study Officials

• Roland E Schmieder, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: July 6, 2012

Record last verified: 2012-07

Locations

DE (1)