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

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00438945
First received: February 20, 2007
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Essential Hypertension
Drug: Eprosartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

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

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

Estimated Enrollment: 18
Study Start Date: January 2007
Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Regional Hospital Holstebro

Additional 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
Study First Received: February 20, 2007
Last Updated: May 5, 2008
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eprosartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 2 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014