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

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

Condition(s) targeted: Healthy

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, Denmark

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.

Clinical Details

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

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

Primary outcome:

Heart rate

Fractional sodium excretion

Plasma levels of noradrenaline

Eligibility

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

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.

Locations and Contacts

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

Starting date: November 2006
Last updated: September 13, 2007

Page last updated: August 23, 2015

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