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

September 13, 2007 updated by: Regional Hospital Holstebro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fractional sodium excretion
Heart rate
Plasma levels of noradrenaline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital Holstebro

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Registration Dates

First Submitted

December 10, 2006

First Submitted That Met QC Criteria

December 11, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 14, 2007

Last Update Submitted That Met QC Criteria

September 13, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED.RES.HOS.2006.02.HV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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