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

NCT ID: NCT00409903

Last Updated: 2007-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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Eprosartan

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Principal Investigators

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Erling B Pedersen, MD, professor

Role: STUDY_CHAIR

Department of Medical Research, Holstebro Hospital, Denmark

Locations

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Department of Medical Research, Holstebro Hospital

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MED.RES.HOS.2006.02.HV

Identifier Type: -

Identifier Source: org_study_id