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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409903
• Other study ID #: MED.RES.HOS.2006.02.HV
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2006
• Last updated: September 13, 2007
• Start date: November 2006

Study information

• Verified date: September 2007
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• 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 healthy individuals - during baseline conditions and after activation of the sympathetic nervous system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

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