The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans. - Full Text View

The Effect of Eprosartan on Hormones and Kidney Function in Healthy Humans.

This study has been completed.

Sponsored by:	Holstebro Hospital
Information provided by:	Holstebro Hospital
ClinicalTrials.gov Identifier:	NCT00409903

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Eprosartan	Phase IV

Drug Information available for:

Eprosartan Eprosartan mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Crossover Assignment

Official Title:	The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.

Further study details as provided by Holstebro Hospital:

Primary Outcome Measures:

Heart rate
Fractional sodium excretion
Plasma levels of noradrenaline

Estimated Enrollment:	18
Study Start Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Both genders.
Age 18 - 65 years.
Body mass index less or equal to 30 kg/m2.
Women must use oral hormonal anticonception, use intrauterine anticonceptive device, be sterilized/hysterectomized or be postmenopausal.

Exclusion Criteria:

History or clinical signs of heart, lung, kidney, or endocrine organ disease.
Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
Abnormal screening of the urine regarding: albumin and glucose
Malignant disease.
Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
Alcohol abuse.
Smoking.
Drug use or abuse.
Known intolerance or allergy to eprosartan or sodium nitroprusside.
Blood donation within 1 month of the start of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409903

Locations


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

Sponsors and Collaborators

Holstebro Hospital

Investigators


Study Chair:	Erling B Pedersen, MD, professor	Department of Medical Research, Holstebro Hospital, Denmark

More Information

Study ID Numbers:	MED.RES.HOS.2006.02.HV
First Received:	December 10, 2006
Last Updated:	September 13, 2007
ClinicalTrials.gov Identifier:	NCT00409903
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Eprosartan

Healthy

Angiotensin II

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008