The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

Essential Hypertension Clinical Trial

Official title:

The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438945
• Other study ID #: MED.RES.HOS.2006.03.HV
• Status: Completed
• Phase: Phase 4
• First received: February 20, 2007
• Last updated: May 5, 2008
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2008
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 - 65 years.

• Body mass index less or equal to 30 kg/m2.

• Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.

• Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion Criteria:

• History of myocardial infarction.

• History of stroke.

• Heart failure.

• Endocrine organ disease.

• Lung disease.

• Clinically significant abnormal biochemical screening of the blood regarding:

B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.

• Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).

• Renovascular hypertension.

• Malignant disease.

• Alcohol abuse.

• Usage of medical drugs besides antihypertensives or statins.

• Drug abuse.

• Pregnancy or breast feeding.

• Known intolerance or allergic to eprosartan or sodium nitroprusside.

• Blood donation within 1 month of the start of the study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Eprosartan

Locations

Country	Name	City	State
Denmark	Department of Medical Research, Holstebro Hospital	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate
Primary	Fractional sodium excretion
Primary	Plasma levels of noradrenaline
Secondary	Fractional lithium excretion
Secondary	Glomerular filtration rate
Secondary	plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide
Secondary	free water clearance
Secondary	urinary excretion of aquaporin 2