Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00409903
First received: December 10, 2006
Last updated: September 13, 2007
Last verified: September 2007
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

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

No publications provided

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

Additional relevant MeSH terms:
Hormones
Eprosartan
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013