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The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT00438945
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:
Regional Hospital Holstebro

Brief Summary:
We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Eprosartan Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.
Study Start Date : January 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources




Primary Outcome Measures :
  1. Heart rate
  2. Fractional sodium excretion
  3. Plasma levels of noradrenaline

Secondary Outcome Measures :
  1. Fractional lithium excretion
  2. Glomerular filtration rate
  3. plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide
  4. free water clearance
  5. urinary excretion of aquaporin 2


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 65 years.
  • Body mass index less or equal to 30 kg/m2.
  • Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal.
  • Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic.

Exclusion Criteria:

  • History of myocardial infarction.
  • History of stroke.
  • Heart failure.
  • Endocrine organ disease.
  • Lung disease.
  • Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose.
  • Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted).
  • Renovascular hypertension.
  • Malignant disease.
  • Alcohol abuse.
  • Usage of medical drugs besides antihypertensives or statins.
  • Drug abuse.
  • Pregnancy or breast feeding.
  • Known intolerance or allergic to eprosartan or sodium nitroprusside.
  • Blood donation within 1 month of the start of the study.

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): NCT00438945


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, Department of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00438945     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.03.HV
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
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