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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409903
First Posted: December 12, 2006
Last Update Posted: September 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  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
Official Title: The Effect of Eprosartan on Vasoactive Hormones and Renal Tubular Function in Healthy Humans.

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00409903     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.02.HV
First Submitted: December 10, 2006
First Posted: December 12, 2006
Last Update Posted: September 14, 2007
Last Verified: September 2007

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