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

Information source: Regional Hospital Holstebro
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Eprosartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Regional Hospital Holstebro

Official(s) and/or principal investigator(s):
Erling B Pedersen, MD, professor, Study Chair, Affiliation: Department of Medical Research, Holstebro Hospital

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.

Clinical Details

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.

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

Primary outcome:

Heart rate

Fractional sodium excretion

Plasma levels of noradrenaline

Secondary outcome:

Fractional lithium excretion

Glomerular filtration rate

plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide

free water clearance

urinary excretion of aquaporin 2

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 ┬Ámol/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.

Locations and Contacts

Department of Medical Research, Holstebro Hospital, Holstebro 7500, Denmark
Additional Information

Starting date: January 2007
Last updated: May 5, 2008

Page last updated: August 23, 2015

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